Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

Key facts

Study ID

NCT02744755

Run by

Sandoz

People needed

353

Starts

2016-03-31

Expected to finish

2017-09-26

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have been diagnosed with RA ≥ 6 months prior to screening
• Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
• Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
• Patients must have had inadequate clinical response to MTX 10 - 25 mg/week

You may not qualify if…

• Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
• Nursing (lactating) or pregnant women
• History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
• Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline
• History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
• History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
• Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
• History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
• History of persistent chronic infection; recurrent infection or active infections
• History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON-TB Gold test (QFT)
• History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
• Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections

Where it is running

• Sun Valley Arthritis Center Ltd. — Peoria, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• MD Med Corp — Hemet, California, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Joao Nascimento (Private Practice) — Bridgeport, Connecticut, United States
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
• RASF - Clinical Research Center — Boca Raton, Florida, United States
• QPS MRA (Miami Research Associates) — Miami, Florida, United States
• Omega Research Consultants Orlando — Orlando, Florida, United States
• Family Clinical Trials, LLC. — Pembroke Pines, Florida, United States
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
• McIlwain Medical Group, PA — Tampa, Florida, United States
• BayCare Medical Group, Inc — Tampa, Florida, United States
• Lovelace Scientific Resources, Inc. — Venice, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Marietta Rheumatology Associates, PC — Marietta, Georgia, United States
• Center for Arthritis & Osteoporosis — Elizabethtown, Kentucky, United States
• Arthritis and Rheumatology Consultants — Edina, Minnesota, United States
• Physician Research Collaboration — Lincoln, Nebraska, United States
• Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
• Montefiore Medical Center PRIME — Lake Success, New York, United States
• Medication Management, LLC — Greensboro, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Arizona Arthritis & Rheumatology — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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