Clinical trial NCT01285310: Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid, Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.


Eligibility criteria: Inclusion Criteria:

* Must have a documented diagnosis of Rheumatoid Arthritis (1987 American College of Rheumatology Criteria) with onset of signs/symptoms of disease ≥ 4 months of duration from randomization.
* Must be receiving treatment on an outpatient basis.
* Must have active disease despite current methotrexate treatment as defined below:

  * ≥ 6 swollen joints (66 swollen joint count) AND
  * ≥ 6 tender joints (68 tender joint count)

    -. Must meet at least one of the four lab requirements below:
  * High Sensitivity C-Reactive Protein (hsCRP) ≥ 10 mg/L
  * Erythrocyte Sedimentation Rate (ESR) \> 28 mm after the first 1 hour
  * Positive for Rheumatoid Factor (RF)
  * Positive for Anti-cyclic Citrullinated Peptide (anti-CCP) antibodies
* For participants participating in the Magnetic Resonance Imaging (MRI) assessment:

  • Must have Rheumatoid Arthritis joint involvement, as assessed by swollen joint counts in: 1) at least two Metacarpophalangeal (MCP) swollen joints on the same hand, or 2) at least one swollen Metacarpophalangeal (MCP) joint and swollen wrist on the same hand.
* Must have been treated with methotrexate for at least 4 months prior to randomization, and must be on stable dose. Participants will be required to maintain their stable dose through Week 52 of the study. Oral folate (folic acid) supplementation is required with a minimum dose of 5 mg/week, or instead leucovorin may be used up to 10 mg/week orally.

  • Non-steroidal anti-inflammatory drugs (NSAIDs) and pain medications are allowed, however, must be on stable regimen for at least 7 days prior to randomization and through Week 52 of the study.
* Oral corticosteroids (if taken) are allowed, however, must be on stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to randomization and through Week 52 of the study.
* Must meet the following laboratory criteria at screening:

  * White blood cell count ≥ 3000/mm\^3 (≥ 3.0 x 10\^9/L) and \< 14,000/mm\^3 (\< 14 x 10\^9/L)
  * Platelet count (≥ 100,000/μL ((≥ 100 x 10\^9/L)
  * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
  * Aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase or serum glutamic-pyruvic transaminase (ALT/ SGPT) ≤ 2 x upper limit of normal (ULN). If initial test shows Aspartate aminotransferase (AST) or alanine aminotransferase (SLT) or 2 times the upper limit of normal (ULN), one repeat test is allowed during the screening period.
  * Total bilirubin ≤ 2 mg/dL (≤ 34 μmol/L). If initial test result is \> 2 mg/dL, one repeat test is allowed during the screening period.
  * Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
  * Hemoglobin A1c ≤ 9.0%
  * Negative for hepatitis B surface antigen
  * Negative for hepatitis C antibody
* Males who engage in activity in which conception is possible must use protocol described barrier contraception while on Investigational Product and for at least 28 days after the last dose of Investigational Product.
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use protocol described contraception while on Investigational Product and for at least 28 days after taking the last dose or Investigational Product.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
* Rheumatic autoimmune disease other than Rheumatoid Arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to Rheumatoid Arthritis (eg, vasculitis, pulmonary fibrosis or Felty syndrome). Sjögren syndrome secondary to Rheumatoid Arthritis is allowable.
* Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
* Prior history of, or current, inflammatory joint disease other than Rheumatoid Arthritis (eg, gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis, Lyme disease).
* Receiving treatment with Disease-modifying antirheumatic drugs (DMARDs) (other than methotrexate), including biologic Disease-modifying antirheumatic drugs (DMARDs)Previous use is only allowed after adequate washout prior to randomization.
* Inadequate response to treatment with an anti-tumor necrosis factor (anti-TNF) agent. Patients who terminated previous anti-tumor necrosis factor (anti-TNF) treatment due to cost or safety reason, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout.
* Treatment with any investigational agent within four weeks (or five half-lives of the investigational drug, whichever is longer) of screening.
* Previous treatment with any cell depleting therapies, including investigational agents.
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba® column within 6 months of baseline.
* Intra-articular or parenteral corticosteroids are not allowed within 6 weeks prior to randomization.
* Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
* Pregnant women or nursing (breast feeding) mothers.
* Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including severe or very severe chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus as defined by Hemoglobin A1c \> 9.0%) or gastrointestinal (GI) disease.
* Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
* History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
* History of malignancy, including solid tumors and hematologic malignancies (except basal cell carcinoma of the skin that has been excised and cured).
* History of alcohol, drug or chemical abuse within the 6 months prior to screening.
* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
* Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
* Any condition that in the investigator's opinion would interfere significantly with the efficacy evaluations, including the pain and joint assessments (eg, fibromyalgia).

For Magnetic Resonance Imaging (MRI) Only:

* Receiving medication(s) or will require medication(s) during the study that impact on vascular flow (eg, nitrates, calcium channel blockers, ergot containing drugs) on the day of the Magnetic Resonance Imaging (MRI test and in the investigator's judgement the subject cannot hold back from taking these medications on the day of the Magnetic Resonance Imaging (MRI) prior to the Magnetic Resonance Imaging (MRI) test. The subject can continue taking the medication(s) at any time after the Magnetic Resonance Imaging (MRI) test is completed, as clinically indicated and scheduled. Exclusions of antihypertensive and migraine medications can be determined after discussion with the Sponsor.
* Unable to undergo an Magnetic Resonance Imaging (MRI) examination, including but not limited to the presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip, pedicle screws, or any other metal contained in the body (eg, such as tattoos that contain metallic pigment, or metal in the eyes from metal grinding \[eg, a metal worker, etc\]), or severe claustrophobia, or any other contraindication to an Magnetic Resonance Imaging (MRI) as per local imaging center guidelines.
* Allergic or adverse reactions to gadolinium
* Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2 (based on the Modification of Diet in Renal Disease \[MDRD\] formula).

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Tender Joint Count at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Swollen Joint Count at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Subject Assessment of Pain at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Disease Activity Score 28 (DAS28) Using CRP at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Tender Joint Count at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Swollen Joint Count at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Subject Assessment of Pain at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Tender Joint Count at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Swollen Joint Count at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Subject Assessment of Pain at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 52
timeFrame: Baseline and Week 52
measure: Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Year 2
timeFrame: Baseline and Year 2
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Year 2
timeFrame: Baseline and Year 2
measure: Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Year 2
timeFrame: Baseline and Year 2
measure: Change From Baseline in the Clinical Disease Activity Index (CDAI) at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Year 2
timeFrame: Baseline and Year 2
measure: Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Year 2
timeFrame: Baseline and Year 2
measure: Percentage Change From Baseline in the Individual American College of Rheumatology Components at Year 2
timeFrame: Baseline and Year 2
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Year 2
timeFrame: Baseline and Year 2
measure: Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Year 2
timeFrame: Baseline and Year 2
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: ArthroCare, Arthritis Care Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: La Mesa
country: United States
facility: TriWest Research Associates
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Roseville
country: United States
facility: Med Investigations/Sierra
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Doral
country: United States
facility: In Vivo Clinical Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Naples
country: United States
facility: Jeffrey Alper, MD Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Vero Beach
country: United States
facility: Alastair Kennedy, MD
state: Florida
city: Michigan City
country: United States
facility: LaPorte County Institute for Clinical Research, Inc.
state: Indiana
city: Battle Creek
country: United States
facility: Associated Internal Medicine Specialists, PC
state: Michigan
city: Eagan
country: United States
facility: Saint Paul Rheumatology
state: Minnesota
city: Greenville
country: United States
facility: Physician's East
state: North Carolina
city: Mayfield
country: United States
facility: David R. Mandel, M.D., Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Dallas
country: United States
facility: Metroplex Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Stone Oak Rheumatology
state: Texas
city: Williamsburg
country: United States
facility: Center for Excellence in Aging and Geriatric Health
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest, Rheumatology
state: Washington
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Hlucin
country: Czechia
facility: L.K.N. Arthrocentrum s.r.o.
city: Hostivice
country: Czechia
facility: ARTMEDI UPD s.r.o.
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Praha
country: Czechia
facility: Revmatologicka ambulance
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou
city: Zlin
country: Czechia
facility: PV - MEDICAL, s.r.o.
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
city: Bialystok
country: Poland
facility: NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Gdynia
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: Katowice
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne (408)
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Pawel Hrycaj
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: A Coruña
country: Spain
facility: Hospital Universitario a Coruña
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Genovese MC, Jarosova K, Cieslak D, Alper J, Kivitz A, Hough DR, Maes P, Pineda L, Chen M, Zaidi F. Apremilast in Patients With Active Rheumatoid Arthritis: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study. Arthritis Rheumatol. 2015 Jul;67(7):1703-10. doi: 10.1002/art.39120.