rheumatism Rheumatoid Arthritis
Conditions
Interventions
The study is compromised of a 12 week double-blind, placebo-controlled period,
a double-blind long term extension (LTE) of 66 weeks, and a follow-up visit 70
days after the last dose of the study dr
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA. 2. Participant has >= 6 swollen joints (based on 66 joint count) and >= 6 tender joints (based on 68 joint count) at baseline. 3. Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) treatment for RA. 4. Participants must be on stable dose of methotrexate (MTX).
Exclusion criteria
Exclusion criteria: 1. Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of 50% improvement as measured by American College of Rheumatology response criteria (ACR50) at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Disease Activity Score (DAS) 28 (CRP) from Baseline; 2. Change in Clinical Disease Activity Index (CDAI) from Baseline; 3. Achievement of ACR20; 4. Achievement of ACR70; 5. Achievement of Low Disease Activity (LDA) defined by DAS28 (CRP) | — |
Countries
Netherlands
Outcome results
None listed