BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: BIIB023; Other: Placebo (sterile normal saline)

• Registration Number: NCT00771329
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BIIB023	BIIB023
2	Placebo (sterile normal saline)	-

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.	Baseline through Day 70

Secondary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (2)

Research Site; 🇺🇸 Oklahoma City, Oklahoma, United States

Research Centre; 🇷🇺 Yaroslavl, Russian Federation