BG9924 in Combination With Methotrexate for Subjects With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00458861

Purpose

This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in subjects with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: BG9924 Other: Placebo Comparator	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Evaluate efficacy of BG9924 in combination with methotrexate in RA patients who have had an inadequate response to anti-TNF therapy [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability of BG9924 in this patient population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this patient population. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: BG9924 Subcutaneous administration of BG9924 given every other week for 12 weeks
2: Placebo Comparator	Other: Placebo Comparator Subcutaneous administration of placebo given every other week for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy

Key Exclusion Criteria:

Medical History

Serious local infection or systemic infection within 3 months of Day 0
History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period

Laboratory Tests

Clinically significant lab tests at screening; or
Positive for hepatitis C antibody or hepatitis B at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458861

Locations

United States, California
Stanford University
Palo Alto, California, United States, 93404

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec Medical Director

Biogen Idec, Cambridge, MA USA

More Information

Responsible Party:	Biogen Idec ( Biogen Idec Medical Director )
Study ID Numbers:	104RA203, EUDRA CT: 2006-005467-26
Study First Received:	March 22, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00458861
Health Authority:	United States: Food and Drug Administration; United Kingdom: Department of Health; Canada: Canadian Institutes of Health Research; Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Biogen Idec:

Active Rheumatoid Arthritis (RA)

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009