BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00771329

Purpose

Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: BIIB023 Other: Placebo (sterile normal saline)	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA. [ Time Frame: Baseline through Day 70 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects [ Time Frame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70 ] [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BIIB023	Drug: BIIB023 Single IV doses of BIIB023 in dose-escalating cohorts
2: Placebo Comparator	Other: Placebo (sterile normal saline) Single IV dose of Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of adult onset RA (functional class I-III) for at least 6 months
Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion Criteria:

History of recurrent infections requiring antibiotic treatment within 12 months
Serious local infection or systemic infection within 3 months
Suffering from rheumatic or autoimmune disease other than RA
History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771329

Locations

United States, California
Research Centre
Palm Desert, California, United States, 92260
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Research Centre
Duncansville, Pennsylvania, United States, 16635
Russian Federation
Research Centre
Moscow, Russian Federation, 119992
Ukraine
Research Centre
Boyan, Ukraine, 60321

Sponsors and Collaborators

Biogen Idec

More Information

Responsible Party:	Biogen Idec ( Medical Director )
Study ID Numbers:	211RA101
Study First Received:	October 10, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00771329
Health Authority:	United States: Food and Drug Administration; Russia: Pharmacological Committee, Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009