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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771329

Enrollment

Registered

2008-10-13

Start date

2008-10-31

Completion date

2011-04-30

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGBIIB023

Single IV doses of BIIB023 in dose-escalating cohorts

OTHERPlacebo (sterile normal saline)

Single IV dose of Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
• 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

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026