Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab - GP2017; Adalimumab - US licensed Humira
Intervention description: Adalimumab - GP2017; Adalimumab - US licensed Humira
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have been diagnosed with RA ≥ 6 months prior to screening

          2. Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening

          3. Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of
             normal

          4. Patients must have had inadequate clinical response to MTX 10 - 25 mg/week

        Exclusion Criteria:

          1. Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting
             agents, e.g. anti-CD20 therapy

          2. 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

          3. Nursing (lactating) or pregnant women

          4. History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed
             connective tissue disease, systemic lupus erythematosus etc.

          5. Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline

          6. 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

          7. 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)

          8. Subject known to have immune deficiency, history of positive human immunodeficiency
             virus (HIV) status or immunocompromised for other reasons

          9. History of clinically significant hematologic (e.g. severe anemia, leucopenia,
             thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis,
             cirrhosis, hepatitis)

         10. History of persistent chronic infection; recurrent infection or active infections

         11. 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)

         12. History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis,
             legionellosis

         13. Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive
             HCV-Ab or HCV-RNA) indicative of previous or current infections