Clinical trial NCT02722044: Usability of an AI for M923 in Subjects With Moderate to Severe RA
Official title: An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Momenta Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)


Eligibility criteria: Inclusion Criteria:

1. Participants ≥18 years old at the time of Screening
2. Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
3. RA diagnosed for at least 6 months before Screening
4. Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
5. Active disease at Screening and Baseline
6. Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor
7. Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s)
8. Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose.
9. Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.

Exclusion Criteria:

1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
2. Prior use of rituximab
3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
4. Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
6. Current use of oral corticosteroids at a dose \>10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
7. Current use of more than 1 nonsteroidal anti-inflammatory drug.
8. Prior use of injectable corticosteroids (intramuscular \[IM\], intra-articular \[IA\], or intravenous \[IV\]) within 6 weeks prior to Baseline
9. Prior or current use of other self-injected drugs, eg, insulin
10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
11. Meets Class IV Steinbrocker criteria for disability/activities of daily living
12. Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
14. Joint surgery within the last 8 weeks prior to Screening
15. Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
17. History or presence of Class III or IV New York Heart Association congestive heart failure
18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
19. Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas
20. Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)
21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus
22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
23. Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
24. Participant is a family member or employee of the Investigator or Baxalta or its partners

Primary outcomes:
measure: Usability of the Auto-injector (AI) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Number of Participants With Successful Injections as Assessed by the Observer at Week 4
timeFrame: Week 4
measure: Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4
timeFrame: Week 4
measure: Usability of the Auto-injector at Baseline
timeFrame: Baseline (Day 1)
measure: Usability of the Auto-injector at Week 2
timeFrame: Week 2
measure: Number of Participants With Successful Injections as Assessed by the Observer at Baseline
timeFrame: Baseline (Day 1)
measure: Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline
timeFrame: Baseline (Day 1)
measure: Number of Participants With Successful Injections as Assessed by the Observer at Week 2
timeFrame: Week 2
measure: Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2
timeFrame: Week 2
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
timeFrame: Baseline; 32 Weeks
measure: Number of Participants With Vital Signs Outside the Expected Range
timeFrame: 32 Weeks
measure: Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings
timeFrame: Baseline; 32 Weeks
measure: Number of Participants With Adverse Events Leading to Premature Study Withdrawal
timeFrame: 32 Weeks
measure: Number of Participants With Treatment-emergent Injection Site Reactions
timeFrame: 32 Weeks
measure: Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline
timeFrame: Baseline (Day 1)
measure: Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4
timeFrame: Week 4
measure: Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12
timeFrame: Week 12
measure: Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24
timeFrame: Week 24
measure: Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit
timeFrame: Safety Follow-Up Visit (32 Weeks)
measure: Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline
timeFrame: Baseline (Day 1)
measure: Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4
timeFrame: Week 4
measure: Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12
timeFrame: Week 12
measure: Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24
timeFrame: Week 24
measure: Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit
timeFrame: Safety Follow-Up Visit (32 Weeks)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research, PC
state: Pennsylvania
city: Austin
country: United States
facility: Austin Regional Clinic, PA
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Baxalta US Inc., now part of Shire
name: John Caminis, MD
role: STUDY_DIRECTOR
References: