NCT00634933

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-02-01
• Completion: 2012-10-01
• First posted: 2008-03-13
• Last updated: 2013-03-11
• Results posted: 2013-03-11

Locations

65 sites across 10 countries: United States, Belgium, Canada, France, Germany, Hungary, Mexico, Netherlands, Romania, Serbia