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

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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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 ]

Enrollment:	53
Study Start Date:	October 2008
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BIIB023	Drug: BIIB023 Single IV doses of BIIB023 in dose-escalating cohorts Other Name: Human glycosylated IgG1 monoclonal antibody
Placebo Comparator: 2	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, Alabama
Research Site
Anniston, Alabama, United States
United States, California
Research Centre
Palm Desert, California, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Centre
Duncansville, Pennsylvania, United States
Russian Federation
Research Centre
Moscow, Russian Federation
Research Centre
Yaroslavl, Russian Federation

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Medical Director, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00771329 History of Changes
Other Study ID Numbers:	211RA101
Study First Received:	October 10, 2008
Last Updated:	June 7, 2012
Health Authority:	Russia: Pharmacological Committee, Ministry of Health United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013