Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) (OPERA)
Optimized treatment algorithm in early rheumatoid arthritis:
Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Optimized Treatment Algorithms for Patients with Early RA
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis|
- Number of patients who achieve a DAS28 < 3.2 [ Time Frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28) ] [ Designated as safety issue: No ]
- Changes in DAS28 from start of treatment [ Time Frame: 1, 3, 6, 9, 12 and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: methotrexate + adalimumab
Methotrexate and intraarticular triamcinolone hexacetonide plus adalimumab.
Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
Other Name: Humira
Placebo Comparator: methotrexate + placebo
Methotrexate and intraarticular triamcinolone hexacetonide and placebo
Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
Other Name: Saline
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown.
The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans.
Adverse events will also be registered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660647
|Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Principal Investigator:||Kristian Stengaard-Pedersen, Professor||Aarhus University/Aarhus University Hospital|
|Principal Investigator:||Kim Hørslev-Petersen, Professor||King Christian X's Rheumatism Hospital, Graasten, Denmark|