BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771329
• Other study ID #: 211RA101
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2008
• Last updated: September 12, 2013
• Start date: October 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BIIB023
Single IV doses of BIIB023 in dose-escalating cohorts

Other:
• Placebo (sterile normal saline)
Single IV dose of Placebo

Locations

Country	Name	City	State
Russian Federation	Research Centre	Moscow
Russian Federation	Research Centre	Yaroslavl
United States	Research Site	Anniston	Alabama
United States	Research Centre	Duncansville	Pennsylvania
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Centre	Palm Desert	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.		Baseline through Day 70	Yes
Secondary	• 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	No