BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
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.
1 other identifier
interventional
53
2 countries
6
Brief Summary
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Oct 2008
Typical duration for phase_1 rheumatoid-arthritis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedSeptember 16, 2013
May 1, 2011
2.5 years
October 10, 2008
September 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Baseline through Day 70
Secondary Outcomes (1)
• 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
Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
Study Arms (2)
1
EXPERIMENTALBIIB023
2
PLACEBO COMPARATORInterventions
Single IV doses of BIIB023 in dose-escalating cohorts
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (6)
Research Site
Anniston, Alabama, United States
Research Centre
Palm Desert, California, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Centre
Duncansville, Pennsylvania, United States
Research Centre
Moscow, Russia
Research Centre
Yaroslavl, Russia
Related Publications (1)
Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6.
PMID: 23928094DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 16, 2013
Record last verified: 2011-05