Clinical trial NCT02030028
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis ACTH gel
Sponsor: Dana Ascherman
Start date: 2014-11-01; Completion date: 2022-06-30
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.

ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.

Detailed description:
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.

Arms: arm 1: Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
Interventions: intervention 1: ACTHAR gel
Intervention descriptions: intervention 1: Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.

Protocol documents:
Prot_SAP_000.pdf: 
1 
 
Open Label Study to evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic 
Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis.  
Protocol Version: 0.01 / 04/Apr/2022 
Clinical Trials.gov: NCT02030028 
 
Principal Investigator:  
Dana Ascherman, MD 
 
 
 
 
University of Pittsburgh  
 
 
 
 
Division of Rheumatology and Clinical Immunology 
 
 
 
 
Seventh Floor, Biomedical Science Tower, South Wing 
 
 
 
 
200 Lothrop Street 
 
 
 
 
Pittsburgh, PA 15261 
 
 
 
 
412-383-8734 
 
Trial design: open label for 12 weeks 
Dose/Route/Regimen: ACTHAR gel 80u subcutaneously twice weekly 
Target population: 20 refractory adult Rheumatoid arthritis patients  
 
Glossary of terms in protocol: 
RA = rheumatoid arthritis  
CDAI = clinical disease activity index  
DAS = disease activity score 
ESR = Erythrocyte sedimentation rate 
CRP = C-reactive protein  


2 
 
 
A. Background and Rationale: 
Adrenocorticotropic hormone (ACTH) gel (repository corticotropin injection) (ACTHAR) is 
a long-acting full sequence ACTH that includes other pro-opiomelanocortin peptides (1-
6). ACTH is thought to have anti-inflammatory prospects as well as immunomodulatory 
effects mediated through melanocortin receptors (2). ACTH gel is FDA approved for 
several immune-mediated disorders including rheumatoid arthritis (RA), multiple 
sclerosis, systemic lupus erythematosus, polymyositis, nephrotic syndrome, and 
infantile spasm syndromes (1-6).  
 
RA is a chronic systemic autoimmune inflammatory arthropathy of unknown etiology 
(7).  The worldwide prevalence is approximately 1% of adults of all races. Disease onset 
occurs most often between the ages of 20 and 60 years, with peak occurrences at 50 to 
60 years. The prevalence of RA varies with sex and age, and is higher in women than in 
men. Affected subjects experience considerable morbidity, including symptoms such as 
joint stiffness, pain and swelling, rapid loss of function, joint destruction, permanent 
deformity as well as a reduced life expectancy.  
 
The treatment of RA has seen a dramatic paradigm shift over the past decade with the 
introduction of biologic response modifiers (5 that inhibit tumor necrosis factor, 1 
inhibitor of interleukin-1, 1 that blocks interleukin-6, 1 that inhibits B-cells, and 1 that 
blocks co-stimulatory pathways), plus most recently an oral agent that blocks Janus 


3 
 
Kinase pathways.  In addition, treatment with standard oral medications such as triple 
oral disease modifying drugs (DMARDs) also are effective options (7).   Despite these 
advances, a large percentage of our patients require daily therapy with oral prednisone 
and/or don’t respond to these current therapies. Thus, safe new therapies are still 
needed for this common immune-mediated inflammatory disease.  
 
B. Hypothesis and Specific Aims: 
 
Hypothesis: Patients with RA, who are receiving stable doses of background 
medications will have an improvement in disease activity (as measured by CDAI) when 
treated with 12 weeks of subcutaneous ACTHAR.  
Specific aim 1:  
To determine the efficacy and safety of ACTH gel in refractory RA  
 
 
 
patients.  
Specific aim 2:  
To determine the potential mechanisms of action of ACTH gel,  
 
 
 
pending review of efficacy data.  
 
C. STUDY Design: 
The proposed trial design would be open-label with a subcutaneous dose of ACTHAR 80 
units, twice a week, for 12 weeks. The entry criteria would be: 
1. 
RA diagnosis by ACR criteria 
2. 
Active disease (CDAI > 10) (8, 9, 10) 
3. 
Have received at least are biologic agent for at least 6 months 


4 
 
4. 
May or may not be receiving oral daily steroids (less than or equal 
 
to 20 mg/day) of prednisone equivalent  
5. 
No current active infections requiring antibiotics 
6. 
Patients must be on stable doses of RA therapies (e.g., 
 
methotrexate or other RA therapies for at least 4 weeks prior to 
 
baseline visit) 
Table 1.  Proposed Study Visits and Study Activities   
 
Screening 
Baseline 
2wk 
4wk 
8wk 
12wk 
16wk 
Informed Consent 
X 
 
 
 
 
 
 
Dispense 
medication 
 
X 
 
X 
X 
X 
 
Clinical Labs* 
X 
 
X 
X 
X 
X 
X 
AE Monitoring 
 
 
X 
X 
X 
X 
X 
Efficacy 
assessments  
 
X 
X 
X 
X 
X 
X 
Research Labs 
(PBMC’s, serum, 
plasma, RNA) 
 
X 
X 
X 
X 
X 
X 
*CBC, glucose, creatinine, ESR, CRP, ALT 
 
Patient population and estimated sample size: Patients will be recruited from UPMC 
Rheumatology Outpatient Clinics. A pilot study of 20 patients will provide initial 
information on efficacy of this agent in refractory RA patients. For the year ending in 
Spring 2012, we had over 4,000 unique, active RA patients in our outpatient clinics.  We 
have 35 Rheumatologists who practice at UPMC in Western, PA.  
 


5 
 
Primary end-points: 
 
1. Changes in CDAI at week-12 (9); we propose a 20% improvement after 12 
 
week of therapy compared to baseline as a positive response.  
 
Secondary end points: 
 
1. Changes in DAS28-CRP (9, 10) 
 
2. Changes in acute phase reactants (ESR, CRP) 
 
3. Changes in fatigue, as measured by FACIT (11).   
 
D. Data Analysis: 
We will determine the frequency of subjects who have at least a 20% improvement in 
CDAI from baseline to week 12 visit.  We will document the frequency and events of 
adverse event.   For secondary endpoints we will also determine frequency of subjects 
what have at least 20% improvement in DAS28-CRP, fatigue, ESR and CRP from baseline 
to week 12.  
E. Data captured and Database: 
The Division of Rheumatology and Clinical Immunology has experience spanning four 
decades in the development, maintenance and refinement of disease-specific databases 
of longitudinal cohorts of patients with rheumatic diseases.  In the past few years we 
have developed a web-based database that we plan to use for this investigator-initiated 
trial.  The key characteristics of the Rheumatic Disease Musculoskeletal System (RDMS) 
are: 1) the ability for longitudinal data collection and database management of data 


6 
 
from multiple clinic visits;  2) the ability to use multiple methods of data entry (e.g., 
web-based, tablet-based, or manual from hard copy) that permit secure data collection 
at various UPMC clinics,  other institutions or Academic Medical Centers; 3) data 
capture and synthesis in real-time has the ability to provide immediate feed-back to 
clinic staff and patients with regards to the data collected and trends over time; 4) 
flexibility to meet the needs of diverse researchers and their research questions through 
a modular design allowing for customization of data collection specific to individual 
study questions; 5) adaptability for future research studies through the addition of new 
forms or disease-specific modules; 6) easy accessibility of data for analysis by research 
team members with limited programming and statistical training such as coordinators, 
fellows and faculty; 7) capability for automated downloading and database integration 
of discrete well-defined clinical data, such as medication data, laboratory data and 
imaging data, from other electronic UPMC systems (e.g., EPIC electronic medical record 
system, Medical Archival Record System (MARS)); 8) patient data is separated into 
different data modules (e.g., Health Insurance Portability and Accountability Act (HIPAA) 
identifiers, demographic information, generic connective tissue disease data and 
disease-specific data) with restricted user access and linkage between the HIPAA 
information and other data based on a unique 8-digit subject ID number; 9) a set of 
common definitions for terms and data collection forms used in the database and the 
establishment of a committee to oversee the common definitions and forms; and 10) a 
research biospecimen and sample tracking system module. 
 


7 
 
F. Exploratory future objectives:  
Once the clinical trial is completed we will consider what mechanistic studies to pursue. 
We plan to collect appropriate samples and store in -80% freezer in one of the 
Rheumatology Division’s freezers.  
 
G. Proposed time line: 
Estimated time line (including IRB approval, study initiation, enrollment, study 
completion and submission of publication): 
 
 
2 year trial  
 6-month start-up (develop forms; IRB submission) 
 18-month recruitment and follow-up 
 
H. References: 
1. Catania A, Gatti S, Colombo G, Lipton JM: Targeting melanocortin receptors as a novel 
strategy to control inflammation. Pharmacological Reviews 2004; 56:1-29  
2. Catania A, Lonati C, Sordis A, et al: The melanocortin system in control of inflammation. The 
Scientific World Journal 2010; 10:1840-1855. 
3. Questcor Pharmaceuticals, Inc. H.P. Acthar GelSummary of Product Characteristics (SPC), 
June, 2011.  
4. Gong, R. The renaissance of corticotropin therapy in proteinuric nephropathies. Nat Rev 
Nephrol 2011, 8(2):122-128. 


8 
 
5. Levine, T: Treating refractory dermatomyositis or polymyositis with adrenocorticotropic 
hormone gel: a retrospective case series. Drug Des Devel Ther 2012, 6: 133-139. 
6. Arnason BG, Berkovich, R, Catania, A, Lisak RP, Zaidi M: Mechanisms of action of 
adrenocorticotropic hormone and other melanocortins relevant to the clinical management of 
patients with multiple sclerosis. Multiple Sclerosis Journal 2012, 
http://msj.sagepub.com/content/early/2012/10/01/1352458544 
7. Moreland LW, O’Dell JR, Paulus HE, Curtis JR, Bathon JM, St Clair EW, Bridges SL, Jr., Zhang J, 
McVie T, Howard G, van der Heijde D, Cofield SS: A randomized comparative effectiveness 
study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid 
arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheum 2012, 
64(9):2824-2835. http://www.ncbi.nlm.nih.gov/pubmed/22508468 
8. Salaffi F, Cimminio MA, Leardini G, Gasparini S, Grass W: Disease activity assessment of 
rheumatoid arthritis in daily practice: validity, internal consistency, reliability and congruency of 
the Disease Activity Score including 28 joints (DAS28) compared with the Clinical Disease 
Activity Index (CDAI). Clin Exp Rheumatol 2009, 27(4): 552-559. 
9. Gaujoux-Viala C, Mouterde G, Baillet A, Claudepierre P, Fautrel B, Le Loet X, Maillefert JF: 
Evaluating disease activity in rheumatoid arthritis: which composite index is best? A systematic 
literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI 
and CDAI. Joint Bone Spine 2012, 79(2):149-155. 
http:www.ncbi.nlm.nih.gov/pubmed/21680221 
10. Anderson J, Caplan L, Yazdany J, Robbins MI, Neogi T, Michaud K, Saag KG, O’Dell JR, Kazi S: 
Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology 


9 
 
Recommendations for Use in Clinical Practice. Arthritis Care Res (Hoboken) 2012, 64(5):640-
647. 
11. Webster K, Cella D, Yost K: The Functional Assessment of Chronic Illness Therapy (FACIT) 
Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 
2003, 1:79.   

ICF_001.pdf: 
 
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY 
 
TITLE: Open Label Study to evaluate Efficacy and Safety of Short-Term, Adjunctive 
Adrenocorticotropic Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis 
Document Date: 04/Jun/2020 
Clinical Trials.gov: NCT02030028 


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University of Pittsburgh
School of Medicine
Department of Medicine
 
Division of Rheumatology
and Clinical Immunology
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY
TITLE: Open Label Study to evaluate Efficacy and Safety of Short-Term, Adjunctive 
Adrenocorticotropic Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis 
Principal Investigator:  
Dana Ascherman, MD
200 Lothrop Street
Biomedical Science Tower, S723
Pittsburgh, PA  15261
24 Hour Emergency Contact Number:  412-647-7243/ pager # 2261
Co-Investigators:    
Larry Moreland, MD
                                                           Thaddeus Osial, MD
Alan Berg, MD
Yong Gil Hwang, MD
Kimberly Liang, MD
Kenneth Gold MD
Source of Support:
Questor Pharmaceuticals, Inc.
It is very important that you read and understand the following information.  Please feel free to 
ask the study doctor or the research staff any questions that will help you understand the study 
and what you are expected to do.  Before you agree to take part in this study, you may take this 
information home and discuss it with a family member or your family doctor.
Why is this research being done?
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease 
the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking 
medications prescribed by their physician and are still experiencing disease symptoms. 
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid 
Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. 
Despite its FDA approval there is very limited data on its how well ACTH gel works in improving 
the symptoms of people with RA.
Who is being asked to take part in this research study?
You are being asked to participate in this study because you have Rheumatoid Arthritis (RA) 
and because you have been taking medicine prescribed by your doctor to improve your RA for 
at least six months but you are still having difficulty with disease symptoms.  You may still have 
tender or swollen joints or your clinical blood tests might show that you still have inflammation 
(swelling) that indicates your disease is not under control. 


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What procedures will be performed for research purposes?
Before any study procedures are done the study doctor and research staff will explain the study 
to you and ask you to read the consent form.  They will answer any questions you may have 
about the study and what you are being asked to do.  If you decide to participate you will be 
asked to sign this consent form and a copy will be given to you.
This study will last a total of four months from the screening visit to the last study visit.  You will 
have a screening visit and a baseline visit.  You will then be seen at two and four weeks after 
your baseline visit, then monthly after that until month four.  Each study visit will last 
approximately 30 minutes and you will see the study physician and the study nurse (research 
coordinator) at each visit.  The study visits will take place where you normally see your doctor.
What you will do at each study visit is describe below:
SCREENING VISIT:
You will discuss the study thoroughly with the study doctor and the study nurse (research 
coordinator).  You will be given the opportunity to ask questions and your questions will be 
answered to your satisfaction.  Then you will be asked to sign this informed consent document 
and a copy of the signed document will be provided to you.
We will obtain a medical history from you about your RA and we will ask you about your current 
RA medications.   The study doctor will give you a limited physical exam, focusing on your RA 
symptoms that includes an assessment of your tender and swollen joints. The joint exam may 
be performed by the study nurse.  The doctor may also ask you about the impact of your 
disease on your daily life.  We will obtain routine clinical blood from you for a Complete Blood 
Count, Glucose levels, Creatinine and ALT (liver function), Sedimentation Rate, and C - reactive 
protein. These are blood tests your doctor would order normally to see how well you are doing 
and to see if you have any inflammation (swelling) in your body. These tests are considered 
standard of care for people with Rheumatoid Arthritis and you or your insurance will be 
responsible for them.
If you are a female of child bearing age, we will ask you to take a urine pregnancy test at each 
study visit.  You will not be required to perform this test at home, however the risks of taking 
ACTH gel, the study medication, while pregnant are unknown so we would ask that you do not 
become pregnant while on this study. If you are pregnant or you become pregnant during this 
study, you cannot participate. The only certain way to prevent pregnancy is to avoid sexual 
activity, however if you are using an appropriate method of birth control such as a female 
diaphragm, intrauterine device, or contraceptive sponge along with a male use of a condom, 
birth control pills, injections or implants and do not become pregnant you will be allowed to 
continue.  The Screening visit will take about 30 minutes to complete
BASELINE VISIT:
The study doctor will give you a limited physical exam, focusing on your RA symptoms, your 
joint pain and/ or tenderness and your ability to perform normal tasks. The joint exam may be 
performed by the study nurse. You will be asked to complete a brief questionnaire describing 
your level activity and the impact your disease has on your ability perform daily tasks   If you are 
a female of child bearing age, we will ask you to take a urine pregnancy test before we give you 
any medication.  We will obtain blood from you in the amount of 2 tablespoons for research 
purposes. These are not routine tests that your doctor would order and you will not know the 
results of these tests. You and/ or your insurance carrier will NOT be responsible for these tests.


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The study nurse will teach you how to give yourself a subcutaneous (under the skin) injection.  
You will be asked to perform this task while the nurse is watching to make sure that you are 
able to this correctly at home.  You will be given enough medication at this visit to last for four 
weeks. The dose of the study medication is 80 units given under the skin twice each week. You 
will be asked to complete a medication diary to document that you are taking the medication as 
prescribed.  The study nurse will give you this diary and show you how to complete it correctly. 
You will also be given a sharps container to dispose of your used syringes.  You will be asked to 
bring the sealed container to your next study visit for the research team to properly dispose of.  
You will be given a new sharps container at each study visit. The baseline study visit will take 
about 30 minutes to complete.
WEEK 2:
The study doctor will give you a limited physical exam, focusing on your RA symptom , your joint 
pain and/ or tenderness and your ability to perform normal tasks. The joint exam may be 
performed by the study nurse.  You will be asked to complete a brief questionnaire describing 
your level activity and the impact your disease has on your ability perform daily tasks.   We will 
obtain routine clinical blood from you for a Complete Blood Count, Glucose levels, Creatinine 
and ALT (liver function), Sedimentation Rate, and C - reactive protein. These are blood tests 
your doctor would order normally to see how well you are doing and to see if you have any 
inflammation (swelling) in your body. These tests are considered standard of care for people 
with Rheumatoid Arthritis and you or your insurance will be responsible for them   We will obtain 
blood from you in the amount of 2 tablespoons for research purposes. These are not routine 
tests that your doctor would order and you will not know the results of these tests. You and/ or 
your insurance carrier will NOT be responsible for these tests.
The study nurse will ask you about any problems you have had giving yourself the medication 
and will ask you experienced any side effects. If you are having difficulty giving yourself the 
medication, the study nurse will review the injection procedure again with you.  The study nurse 
will also ask about any other illness you may have had while taking the study medication.  The 
Week 2 visit will take about 30 minutes to complete.
WEEK 4, WEEK 8, AND WEEK 12:
The study doctor will give you a limited physical exam, focusing on your RA symptoms , your 
joint pain and/ or tenderness and your ability to perform normal tasks.  The joint exam may be 
performed by the study nurse. You will be asked to complete a brief questionnaire describing 
your level activity and the impact your disease has on your ability perform daily tasks.   We will 
obtain routine clinical blood from you for a Complete Blood Count, Glucose levels, Creatinine 
and ALT (liver function), Sedimentation Rate, and C-Reactive Protein. These are blood tests 
your doctor would order normally to see how well you are doing and to see if you have any 
inflammation (swelling) in your body. . These tests are considered standard of care for people 
with Rheumatoid Arthritis and you or your insurance will be responsible for them .  We will 
obtain blood from you in the amount of 2 tablespoons for research purposes. These are not 
routine tests that your doctor would order and you will not know the results of these tests. You 
and/ or your insurance carrier will NOT be responsible for these tests.


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 The study nurse will ask you about any problems you have had giving yourself the medication 
and will ask you experienced any side effects.  The study nurse will also ask about any other 
illness you may have had while taking the study medication.
You will be given enough medication at these visits to last for four weeks.  You will be asked to 
return your completed medication diary and your sharps container with used syringes.  You will 
be given a new medication diary to complete. You will also be given a sharps container to 
dispose of your used syringes.  You will be asked to bring the sealed container to your next 
study visit for the research team to properly dispose of.  You will be given a new sharps 
container at each study visit   These study visits will take about 30 minutes to complete.
WEEK 16 – FINAL STUDY VISIT:
The study doctor will give you a limited physical exam, focusing on your RA symptoms, your 
joint pain and/ or tenderness and your ability to perform normal tasks. The joint exam may be 
performed by the study nurse.  You will be asked to complete a brief questionnaire describing 
your level activity and the impact your disease has on your ability perform daily tasks.   We will 
obtain routine clinical blood from you for a Complete Blood Count, Glucose levels, Creatinine 
and ALT (liver function), Sedimentation Rate, and C-Reactive Protein. These are blood tests 
your doctor would order normally to see how well you are doing and to see if you have any 
inflammation (swelling) in your body. These tests are considered standard of care for people 
with Rheumatoid Arthritis and you or your insurance will be responsible for them .    We will 
obtain blood from you in the amount of 2 tablespoons for research purposes. These are not 
routine tests that your doctor would order and you will not know the results of these tests. . You 
and/ or your insurance carrier will NOT be responsible for these tests.
The study nurse will ask you about any problems you have had giving yourself the medication 
and will ask you experienced any side effects.  The study nurse will also ask about any other 
illness you may have had while taking the study medication.
What are the possible risks, side effects, and discomforts of this research study?
Risks of the Study Drug: 
ACTH gel may cause side effects similar to side effects that happen due to treatment with 
steroid medicines. Not all of these side effects have occurred with ACTH gel but they may 
occur. ACTH gel has been used in the clinical setting for many years; however, if any new risks 
arise, you will be informed of any significant new findings.
Risks associated with the study drug include the following:
Likely 

Increased blood pressure, salt, and water retention or imbalance: ACTH gel can 
cause increases in blood pressure, salt, and water retention, and increased elimination 
of potassium and calcium (minerals essential to your health). Dietary salt restriction and 
potassium supplementation may be necessary. Please let your doctor know if you have 
high blood pressure (hypertension), congestive heart failure, or kidney disease.

Masking of symptoms of other underlying or ongoing disease or disorders: ACTH 
gel may make other diseases less likely to be diagnosed. Your doctor should monitor 
you carefully during and for a period of time following discontinuation of study drug for 


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signs of infection, abnormal heart issues, high blood pressure, high levels of sugar, 
changes in weight, and blood in your stool.

Behavioral and mood changes: ACTH gel may be associated with mood changes 
ranging from euphoria, insomnia, irritability, mood swings, personality changes, and 
severe depression to psychosis (loss of contact with reality). Also existing emotional 
instability or psychotic tendencies may worsen. Please let your doctor know if any of 
these occur or if you have existing conditions that may worsen while receiving study 
drug.

Symptoms of other diseases, such as diabetes and myasthenia gravis (muscle 
weakness), may be worsened: ACTH gel may make some existing diseases, such as 
diabetes, worse. Please let your doctor know if there are any changes to other 
conditions or diseases.
Infrequent 
Infections: There is an increased chance of new infections or reactivations of old infections that 
are no longer active. Please let your doctor know if you have any signs of an infection such as 
fever or discharge or if you have a history of latent tuberculosis.

Adrenal and pituitary gland insufficiency (decreased activity) and a disease called 
Cushing’s syndrome may occur after prolonged use of ACTh Gel. If you are treated 
with ACTH gel for a long period of time, your body may alter its ability to signal between 
glands known as the pituitary and adrenal glands. Let your doctor know if you have any 
weakness, darker areas of skin, weight loss, low blood pressure (hypotension), or 
abdominal pain.
Signs or symptoms of a disease known as Cushing’s syndrome may occur while you are 
receiving study drug but generally resolve after ACTH gel is stopped. Your doctor will 
monitor you for signs and symptoms such as deposition of fat in characteristic sites (e.g., 
moon face), changes in skin color, easily bruise, weight gain, muscle weakness, high 
blood pressure, and high sugar levels.

Certain types of vaccinations should be avoided while on ACTH gel: 
The safety of immunization with any vaccine, particularly live viral vaccines while 
receiving ACTH Gel has not been studied.  Vaccinations (immunizations) against 
infections like the flu, tetanus, etc., work by causing your immune system to produce 
antibodies (molecules that your body makes to fight things like bacteria and viruses).  
Because ACTH Gel works by stopping your immune system from making certain 
antibodies, vaccination may not be fully successful in protecting you against disease.  
You may also experience a potential for increased infections, so it is important to tell 
your doctor if you develop any signs of infection such as red skin, fever, chills and/or 
green or white discharge (pus) from a wound. Please consult with your doctor if you 
need any vaccinations prior to receiving them.

Gastrointestinal (GI) perforation (ulcers) and bleeding: ACTH gel can cause 
stomach or intestinal (GI) bleeding or ulcers, typically with long term use. Symptoms of 
gastrointestinal bleeding are vomiting of blood, bloody bowel movements, or black, tarry 
stools. Please advise your doctor if you have a past history or experience any symptoms 
of GI bleeding.

Eye (ophthalmic) effects such as cataracts, infections, and glaucoma: Prolonged 
use of ACTH gel may result in cataracts (clouding of the lens inside the eye which leads 


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to a decrease in vision) or glaucoma (eye disease in which the optic nerve is damaged). 
There is an increased chance of eye infections as well. Please let your doctor know if 
you have any vision changes.

Decrease in bone density (osteoporosis) in subjects with long term use of ACTH 
Gel: Long term use of ACTH gel may impact your body’s bone density, otherwise known 
as osteoporosis. If you are female, please let your doctor know if you are post-
menopausal. Your doctor will monitor you while you are receiving study drug.
Rare but serious

Immunogenicity (increased immune responses) potential: ACTH gel may alter your 
body’s immune system so that it produces antibodies (agents that may neutralize your 
natural production of ACTH or that may cause you to have an allergic reaction to the 
drug). Please let your doctor know if you are allergic to pigs or experience an allergic 
reaction after injection as ACTH gel has an enhanced effect in subjects with these 
diseases.

Use in subjects with hypothyroidism (low thyroid levels) or liver disease may have 
increased effects of the drug: Please let your doctor know if you have liver disease or 
low thyroid levels. You may need additional blood tests to check liver and 
thyroid function.
Reproductive Risks: ACTH gel may result in death to unborn babies in the womb. There are 
no adequate and well-controlled studies in pregnant women. You should not get pregnant while 
being treated and should alert your doctor if you suspect you might be pregnant. A pregnancy 
test will be conducted to confirm that you are not pregnant at the beginning of this study. 
Avoiding sexual activity is the only certain method to prevent pregnancy.  However, females of 
child-bearing potential must be willing to use an appropriate method of birth control (such as 
female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge, in addition to 
male use of a condom) or the female should be using prescribed “birth control” pills, injections, 
or implants throughout the study.  Even with use of these birth control measures, pregnancy 
could still result.  The risks of receiving the study drug while pregnant include potential loss of 
pregnancy or possible birth defects.  Females of child-bearing potential will undergo a urine 
pregnancy test prior to each exposure to the study drug. 
Other Risks:
There are also risks that are associated with the procedures used in this study, including:
Venipuncture (the process of drawing blood samples)
The risks of drawing blood include temporary discomfort from the needle stick, bruising, 
bleeding, fainting, and rarely, infection.
Subcutaneous (under the skin) Injections
Injections into the skin may be less convenient than other forms of treatment such as oral 
medications. In addition, injections may cause momentary discomfort and other local 
symptoms, such as bleeding, bruising, redness, and, rarely, infection.


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Loss of privacy:  Every effort will be made to protect your privacy and information will be 
handled in a confidential manner.  The only information that will be provided with your 
stored blood is a study code.  Files that link your name to the code number will be kept in a 
locked cabinet and only the study staff will have access to them.  The samples will be 
provided to the researchers in such a manner whereby it will not be possible for them to 
connect your identity with the sample or medical information.  Information about race, 
ethnicity, sex and medical history may be made available to the investigators studying the 
blood samples.  Such information might be important for research. Although no one can 
absolutely guarantee confidentiality, using a code number greatly reduces the chance that 
someone will ever be able to link your name to your sample or to your results.
Confidentiality:  All records pertaining to your involvement in this research study will be 
stored in locked file cabinets. Only a subject number in these records will identify you. Any 
information about your participation in this study will be handled in a confidential manner 
consistent with other identifiable health information. You will not be specifically identified in 
any publication of research results.
Assessment tools for Efficacy (questionnaires): You may feel uncomfortable answering 
questions about your daily activities and how your RA impacts your ability to perform daily 
tasks. 
What are the potential benefits from taking part in this research study?
A possible benefit of this study may be an improvement in your disease symptoms.  However, 
there may be no direct benefit to participants in this study.  There is no guarantee that you will 
receive any personal benefit from participating in this research study. It is hoped that the 
information gained from the study will be beneficial to patients in the future. Because of your 
participation, there may be advancement in knowledge about Rheumatoid Arthritis and 
responses to Acthar Gel drug administration.
What treatment or procedures are available if I decide not to take part in this research 
study?
You do not have to participate in this study to receive treatment for your condition. The study 
drug, ACTH gel, offered in this study is in addition to the medications your doctor has currently 
prescribed for you.   If you decide not to take part in this study or are withdrawn from the study, 
you have the option of having your personal doctor manage your disease using available drugs 
or treatments. The study doctor will discuss these alternative options with you.
If I agree to take part in this research study, will I be told of any new risks that may be 
found during the course of the study?
You will be promptly notified if any new information (either good or bad) develops during the 
conduct of this research study which may cause you to change your mind about continuing to 
participate. If new information is provided to you, your consent to continue participation in this 
study will be re-obtained.
Will I be paid to participate in this study?
You will NOT be paid to participate in this study.  We will provide you with $50.00 at the 
completion of each study visit to help cover the costs of travel and/ or lost wages.  We will also 
provide you with complimentary parking.


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Will I or my insurance provider be charged for the costs of any procedures performed as 
part of this research study?
You or your insurance will not be billed for any research procedures conducted as part of this 
study.  The study drug, Acthar Gel will be provided by Questcor Pharmaceutical, Inc. and there 
will be no cost to you for the study drug.  You and/or your insurance will be billed for standard of 
care costs (not study related) like the routine clinical blood tests or emergent care that you 
receive and you will be responsible for costs not covered by your insurance provider.  You will 
be responsible for any applicable co-pays, co-insurances, and deductibles. 
Who will pay if I am injured as a result of taking part in this research study?
University of Pittsburgh researchers and their associates who provide services at UPMC 
recognize the importance of your voluntary participation in their research studies.  These 
individuals and their staff will make reasonable efforts to minimize, control, and treat any injuries 
that may arise as a result of this research.  If you believe that you are injured as a result of the 
research procedures being performed, please contact immediately the Principal Investigator 
listed on the first page of this form.
Emergency medical treatment for injuries solely and directly related to your participation in this 
research study will be provided to you by the hospitals of UPMC.  It is possible that that UPMC 
may bill your insurance provider for the costs of this emergency treatment, but none of these 
costs will be charged directly to you.  If your research-related injury requires medical care 
beyond this emergency treatment, you will be responsible for the costs of this follow-up care 
unless otherwise specifically stated below.  There is no plan for monetary compensation.  You 
do not, however, waive any legal rights by signing this form.
Who will know about my participation in this research study?
Any information about you obtained from or for this research will be kept as confidential (private) as 
possible.  All records related to your involvement in this research study will be stored in locked file 
cabinets. Your identity on these records will be indicated by a code number rather than by your 
name, and the information linking these code numbers with your identity will be kept separate from 
the research records. You will not be identified by name in any publication of research results unless 
you sign a separate form giving your permission (release).  The University of Pittsburgh policy 
requires that all research records be kept for seven years following the end of a research study.  
At the end of this research study, data (information) will be permanently stored in a research 
consortium database at the University of Pittsburgh, so that data from different Rheumatoid 
Arthritis research studies can be pooled together to make stronger conclusions on how to 
measure the symptoms of this disease. Your identity on this research data will be indicated by a 
code number as indicated above.  Research blood will be used for Rheumatoid Arthritis specific 
and associated auto antibodies. The remainder of the sample will be stored indefinitely in the 
research repository located at the University of Pittsburgh, Division of Rheumatology. 
Will this research study involve the use or disclosure of my identifiable medical 
information?
This research will involve the recording of current and/or future identifiable medical information 
from your hospital and/or other (e.g., physician office) records.  The information that will be 
recorded is limited to the routine clinical blood test performed at the study visits.  These results 
will appear in your medical record and will be recorded in your research file held at University of 
Pittsburgh Division of Rheumatology Offices.  


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Who will have access to identifiable information related to my participation in this 
research study?
In addition to the investigators listed on the first page of this authorization (consent) form and 
their research staff, the following individuals will or may have access to identifiable information 
(which may include your identifiable medical information) related to your participation in this 
research study. 
Authorized representatives of the University of Pittsburgh Research Conduct and Compliance 
Office may review your identifiable research information (which may include your identifiable 
medical information) for the purpose of monitoring the appropriate conduct of this research 
study.
In unusual cases, the investigators may be required to release identifiable information (which 
may include your identifiable medical information) related to your participation in this research 
study in response to an order from a court of law.  If the investigators learn that you or someone 
with whom you are involved is in serious danger or potential harm, they will need to inform, as 
required by Pennsylvania law, the appropriate agencies.
Authorized representatives of the sponsor of this research study ,Questcor Pharmaceutical 
representatives and from the University of Pittsburgh acting as the Clinical Coordinating Center 
for this study will review and/or obtain identifiable information (which may include your 
identifiable medical information) related to your participation in this research study for the 
purpose of monitoring the accuracy and completeness of the research data and for performing 
required scientific analysis of the research data.  The investigators involved in the conduct of 
this research study will receive funding from the sponsor to perform the research procedures 
and to provide identifiable research and medical information related to your participation in the 
study. 
Authorized representatives of the U.S. Food and Drug Administration may review and/or obtain 
identifiable information (which may include your identifiable medical information) related to your 
participation in this research study for the purpose of monitoring the accuracy of the research 
data. While the U.S. Food and Drug Administration understands the importance of maintaining 
the confidentiality of your identifiable research and medical information, the University of 
Pittsburgh and UPMC cannot guarantee the confidentiality of this information after it has been 
obtained by the U.S. Food and Drug Administration. 
Authorized representatives of the UPMC hospitals, Clinical and Translational Research Center 
(CTRC) or other affiliated health care providers may have access to identifiable information 
(which may include your identifiable medical information) related to your participation in this 
research study for the purpose of (1) fulfilling orders, made by the investigators, for hospital and 
health care services (e.g. diagnostic procedures) associated with research study participation; 
(2) addressing correct payment for tests and procedures ordered by the investigators; and/or (3) 
for internal hospital operations (e.g. quality assurance).
For how long will the investigators be permitted to use and disclose identifiable 
information related to my participation in this research study?
The investigators may continue to use and disclose, for purposes described above, identifiable 
information (which may include your identifiable medical information) related to your 
participation in this research study for a minimum of 5 years and for as long (indefinite) as it may 
take to complete this research study.


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May I have access to my medical information that results from my participation in this 
research study?
In accordance with the UPMC Notices of Privacy Practices document that you have been 
provided, you are permitted access to information (including information resulting from your 
participation in this research study) contained within your medical records filed with your health 
care provider unless otherwise specifically stated below.
You agree that, while the study is still in progress, you may not be given access to medical 
information about you that is related to the study.  While a request for access to medical 
information can be denied, the study doctor and staff will not automatically deny a request, but 
will consider whether it’s medically appropriate under the circumstances to allow access.  Your 
agreement that you may be denied access to your study-related medical information during the 
study will not be used to deny you access to that information after the study is completed at all 
locations and study results are analyzed.  As previously stated you will not be permitted access 
to results of the blood analysis.
 
Is my participation in this research study voluntary?
Your participation in this research study, to include the use and disclosure of your identifiable 
information for the purposes described above, is completely voluntary. (Note, however, that if 
you do not provide your consent for the use and disclosure of your identifiable information for 
the purposes described above, you will not be allowed, in general, to participate in the research 
study)  Whether or not you provide your consent for participation in this research study will have 
no effect on your current or future relationship with the University of Pittsburgh. Whether or not 
you provide your consent for participation in this research study will have no effect on your 
current or future care at UPMC hospitals or affiliated health care provider or your current or 
future relationship with a health care insurance provider.
If your doctor is involved as an investigator in this research study, as both your doctor and a 
research investigator, s/he is interested both in your medical care and the conduct of this 
research study.  Before agreeing to participate in this research study, or at any time during your 
study participation, you may discuss your care with another doctor who is not associated with 
this research study.  You are not under any obligation to participate in any research study 
offered by your doctor. 
May I withdraw, at a future date, my consent for participation in this research study?
You may withdraw, at any time, your consent for participation in this research study, to include 
the use and disclosure of your identifiable information for the purposes described above. (Note, 
however, that if you withdraw your consent for the use and disclosure of your identifiable 
medical record information for the purposes described above, you will also be withdrawn, in 
general, from further participation in this research study.)   Any identifiable research or medical 
information recorded for, or resulting from, your participation in this research study prior to the 
date that you formally withdrew your consent may continue to be used and disclosed by the 
investigators for the purposes described above.
To formally withdraw your consent for participation in this research study you should provide a 
written and dated notice of this decision to the principal investigator of this research study at the 
address listed on the first page of this form.
Your decision to withdraw your consent for participation in this research study will have no effect 
on your current or future relationship with the University of Pittsburgh.  Your decision to 
withdraw your consent for participation in this research study will have no effect on your current 
or future medical care at UPMC hospitals or affiliated health care provider or your current or 
future relationship with a health care insurance provider.


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If I agree to take part in this research study, can I be removed from the study without my 
consent?
No guarantee is made as to the results of your participation in this study.  If certain circumstances 
were to occur, the physician may stop the study medication and your participation in this study may 
be terminated without your permission.  These circumstances would be related to either your failure 
to cooperate fully with the conduct of the study, or the recognition of significant medical risks 
associated with your continued participation in this study.  If your participation in this study is stopped, 
the reasons will be discussed with you.
VOLUNTARY CONSENT
All of the above has been explained to me and all of my current questions have been answered.  
I understand that I am encouraged to ask questions about any aspect of this research study 
during the course of this study, and that such future questions will be answered by the 
researchers listed on the first page of this form.  Any questions which I have about my rights as 
a research participant will be answered by the Human Subject Protection Advocate of the IRB 
Office, University of Pittsburgh (1-866-212-2668). 
By signing this form, I agree to participate in this research study.  A copy of this consent form 
will be given to me.
_______________________________        
Printed Name of Participant         
                 
_____________________________     _________________________
Participant’s Signature                           Date  
Time
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named 
individual(s), and I have discussed the potential benefits and possible risks of study 
participation.  Any questions the individual(s) have about this study have been answered, and 
we will always be available to address future questions as they arise.”
___________________________________
________________________
Printed Name of Person Obtaining Consent
Role in Research Study
_________________________________
_________________________
Signature of Person Obtaining Consent
    Date /Time