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Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-7201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any prior use of rituximab or other B cell depleting agents.

- Any significant health problem other than rheumatoid arthritis

- Clinically significant laboratory abnormalities

NCT00634933
Pfizer
Terminated
Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis

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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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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