| Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis |
| A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate |
| This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Arthritis, Rheumatoid |
- Drug: TRU-015
IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
- Drug: Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
- Drug: Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
- Drug: TRU-015
IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
- Drug: Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
- Drug: Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
- Drug: TRU-015
IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
- Drug: Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
- Drug: Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
|
- Experimental: Arm 1
Consists of Arms 1a and 1b
Interventions:
- Drug: TRU-015
- Drug: Methylprednisolone
- Drug: Prednisone
- Experimental: Arm 2
Consists of Arms 2a and 2b
Interventions:
- Drug: TRU-015
- Drug: Methylprednisolone
- Drug: Prednisone
- Placebo Comparator: Arm 3
Consists of Arms 3a and 3b.
Interventions:
- Drug: TRU-015
- Drug: Methylprednisolone
- Drug: Prednisone
|
| Not Provided |
| |
| Terminated |
| 222 |
| October 2012 |
| February 2010 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.
Exclusion Criteria:
- Any prior use of rituximab or other B cell depleting agents.
- Any significant health problem other than rheumatoid arthritis
- Clinically significant laboratory abnormalities
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Canada, France, Germany, Hungary, Mexico, Netherlands, Romania, Serbia, United States |
| Austria |
| |
| NCT00634933 |
3206K1-2203
B2051001 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Trubion Pharmaceuticals/Emergent BioSolutions Inc. |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2013 |
