BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BIIB023
Placebo (sterile normal saline)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Research Site
- Research Centre
- Research Site
- Research Centre
- Research Centre
- Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
BIIB023
Outcomes
Primary Outcome Measures
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00771329
Brief Title
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
BIIB023
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BIIB023
Other Intervention Name(s)
Human glycosylated IgG1 monoclonal antibody
Intervention Description
Single IV doses of BIIB023 in dose-escalating cohorts
Intervention Type
Other
Intervention Name(s)
Placebo (sterile normal saline)
Intervention Description
Single IV dose of Placebo
Primary Outcome Measure Information:
Title
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Time Frame
Baseline through Day 70
Secondary Outcome Measure Information:
Title
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
Research Centre
City
Palm Desert
State/Province
California
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Centre
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Centre
City
Moscow
Country
Russian Federation
Facility Name
Research Centre
City
Yaroslavl
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
23928094
Citation
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.
Results Reference
derived
Learn more about this trial
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs