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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:	Emergent Product Development Seattle LLC
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00634933

Purpose

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.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: TRU-015 Other: Placebo (Part A) - TRU-015 (Part B)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Primary endpoint is the American College of Rheumatology (ACR) 50 response rate at 24 weeks for the modified intent to treat (mITT) population. ACR50 represents 50% improvement from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

American College of Rheumatology (ACR) ACR20 [ Time Frame: all time points ] [ Designated as safety issue: No ]
American College of Rheumatology (ACR) ACR50 [ Time Frame: all time points except W24 ] [ Designated as safety issue: No ]
American College of Rheumatology (ACR) ACR70 [ Time Frame: all time points ] [ Designated as safety issue: No ]
Number of tender joints and number of swollen joints [ Time Frame: collected time points ] [ Designated as safety issue: No ]
Duration of morning stiffness [ Time Frame: collected time points ] [ Designated as safety issue: No ]
Pain VAS [ Time Frame: collected time points ] [ Designated as safety issue: No ]
Physician and Patient global assessments of disease activity [ Time Frame: collected time points ] [ Designated as safety issue: No ]
General Health VAS [ Time Frame: collected time points ] [ Designated as safety issue: No ]
HAQ-DI [ Time Frame: collected time points ] [ Designated as safety issue: No ]
DAS28 [ Time Frame: collected time points ] [ Designated as safety issue: No ]
General quality of life assessed by the SF-36 [ Time Frame: collected time points ] [ Designated as safety issue: No ]
General health status assessed by the EQ-5D [ Time Frame: collected time points ] [ Designated as safety issue: No ]
Fatigue assessed by the FACIT-F [ Time Frame: collected time points ] [ Designated as safety issue: No ]
Work productivity and caregiver burden of subjects assessed by the Productivity and disease burden questionnaire [ Time Frame: collected time points ] [ Designated as safety issue: No ]
EULAR response derived from DAS28 [ Time Frame: collected time points ] [ Designated as safety issue: No ]

Enrollment:	235
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2011
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: TRU-015 IV 800 mg TRU-015 at Baseline in Part A IV 800 mg TRU-015 at Week 24 in Part B
Experimental: Arm 2	Drug: TRU-015 IV 800 mg TRU-015 at Baseline and at Week 12 in Part A IV 800 mg TRU-015 at Week 36 in Part B
Arm 3 Placebo Comparator in Part A (Primary outcome) TRU-015 treatment in Part B	Other: Placebo (Part A) - TRU-015 (Part B) IV Placebo at Baseline and at Week 12 in Part A IV 800 mg TRU-015 at Week 24 and IV 800 mg TRU-015 or Placebo at Week 36 in Part B

Detailed Description:

The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634933

Show 64 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Emergent Product Development Seattle LLC

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00634933 History of Changes
Other Study ID Numbers:	3206K1-2203, B2051001
Study First Received:	March 5, 2008
Last Updated:	June 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

active
rheumatoid
arthritis
anti CD20

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012