| Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects |
| An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel? (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity |
| To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity. |
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Rheumatoid Arthritis |
- Drug: etanercept (EnbrelTM)
- Drug: methotrexate
|
- Active Comparator: Usual care
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
Intervention: Drug: methotrexate
- Active Comparator: ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
Interventions:
- Drug: etanercept (EnbrelTM)
- Drug: methotrexate
|
- Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.
- Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.
|
| |
| Terminated |
| 141 |
| May 2010 |
| December 2009 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
- Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
- Have received MTX as stable dose for 28 days prior to the screening visit.
Exclusion Criteria:
- Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
- Receipt of any DMARD, other than MTX, within 28 days before screening.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Turkey, United Kingdom |
| Austria, Croatia, United States |
| |
| NCT00706797 |
| 0881X1-4437 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Wyeth |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Wyeth is now a wholly owned subsidiary of Pfizer |
|
| Wyeth is now a wholly owned subsidiary of Pfizer |
| June 2011 |
