rheumatoid arthritis MedDRA version: 19.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Sponsors
Hexal, AG
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 278 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Previous treatment with adalimumab, other anti-TNFa 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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate similar efficacy of GP2017 and US-licensed Humira® in patients with moderate to severe active RA with respect to DAS28-CRP score change from baseline to at Week 12.; Secondary Objective: To demonstrate similar efficacy of GP2017 and US-licensed Humira with respect to time-weighted average change from baseline in DAS28-CRP until Week 24. To compare the proportion of GP2017 and US-licensed Humira treated patients achieving European League against Rheumatism (EULAR) criterion for remission, good response and moderate response To compare the proportion of GP2017 and US-licensed Humira treated patients achieving ACR20/50/70 responses To compare Health Assessment Questionnaire-Disability Index (HAQ-DI) changes from baseline in GP2017 and US-licensed Humira treated patients To compare Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale changes from baseline in GP2017 and US-licensed Humira treated patients To compare clinical safety of GP2017 and US-licensed Humira? ? ;Primary end point(s): Measure of the score DAS28-CRP to assess the equivalence between the 2 tretaments.; Timepoint(s) of evaluation of this end point: baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time-weighted average change from baseline in DAS28-CRP until Week 24;Timepoint(s) of evaluation of this end point: baseline and week 24 | — |
Countries
Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactBiopharmaceuticals Clinical Dev.
Hexal, AG
Outcome results
None listed