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Completed

NCT Number: NCT00771329

BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centre, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIIB023

Drug

Single IV doses of BIIB023 in dose-escalating cohorts

Other names: Human glycosylated IgG1 monoclonal antibody

Placebo (sterile normal saline)

Other

Single IV dose of Placebo

Primary outcomes

  1. Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.

    Time frame: 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

    Time frame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2008
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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