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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00634933
Date of registration: 05/03/2008
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
Scientific title: 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
Date of first enrolment: March 2008
Target sample size: 222
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00634933
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Austria Belgium Canada France Germany Hungary Mexico Netherlands
Romania Serbia United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Drug: Methylprednisolone
Drug: Prednisone
Drug: TRU-015
Primary Outcome(s)
Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24 [Time Frame: Week 24]
Secondary Outcome(s)
36-Item Short-Form Health Survey (SF-36) [Time Frame: Baseline, Week 12, 24, 36, 52]
Disease Activity Score Based on 28-joints Count (DAS28) [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Duration of Morning Stiffness [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [Time Frame: Baseline, Week 12, 24, 36, 52]
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) [Time Frame: Baseline, Week 12, 24, 36, 52]
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score [Time Frame: Baseline, Week 12, 24, 36, 52]
General Health Visual Analog Scale (VAS) [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Number of Swollen Joints [Time Frame: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Number of Tender Joints [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Patient Global Assessment (PtGA) of Disease Activity [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52]
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 [Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Physician Global Assessment (PGA) of Disease Activity [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Visual Analogue Scale for Pain (VAS-pain) [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]
Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score [Time Frame: Baseline, Week 12, 24, 36, 52]
Secondary ID(s)
3206K1-2203
B2051001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Trubion Pharmaceuticals/Emergent BioSolutions Inc.
Ethics review
Results
Results available: Yes
Date Posted: 11/03/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00634933
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