A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy

Biogen10 sites in 2 countries50 target enrollmentNovember 2005

ConditionsRheumatoid Arthritis

DrugsBG9924

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Biogen
Enrollment: 50
Locations: 10
Primary Endpoint: To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapy
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF therapy. This study will assist with dose selection for further planned Phase 2 studies.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

May 2007

Last Updated

18 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Biogen

Eligibility Criteria

Inclusion Criteria

•Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).
•Male or female subjects aged 18 to 75 years old, inclusive, at the time informed consent is given.
•Must have a diagnosis of RA Functional Class I-III according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis for at least 6 months prior to baseline.
•Must have been treated with MTX (\>=10 mg/week to \<=25 mg/week) for at least 3 months immediately prior to enrollment. The dose of MTX must be stable for at least 4 weeks prior to Day
•Must have active disease at Screening defined as SJC \>=5 (66 joint count) and TJC \>=5 (68 joint count).
•All DMARDs, other than MTX or hydroxychloroquine sulfate, must be withdrawn at least 4 weeks prior to Day 0 (8 weeks for infliximab, adalimumab, and leflunomide).
•Male and female subjects of child-bearing potential must be willing to practice effective birth control for the duration of the study. Female subjects must be: (1) postmenopausal for at least 12 months, (2) surgically sterile, or (3) willing to use 2 documented forms of birth control (e.g., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide).
•Subjects must be willing and able to complete all planned study procedures.

Exclusion Criteria

•Subjects with a history of a malignancy or carcinoma in situ (subjects with a history of excised or treated basal cell carcinoma are eligible to participate in this study).
•Moles or lesions currently undiagnosed, but suspicious for malignancy.
•Subjects with a history of clinically significant (as determined by the Investigator) cardiac, allergic, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency or major disease.
•Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome is permitted.
•Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to Day
•History of recurrent significant infections.
•Primary or secondary immunodeficiency (history of or currently active).
•History of tuberculosis or positive purified protein derivative (PPD; positive Mantoux test defined as ³10 mm of induration \[size of raised bump, not redness\]) test during the screening period. Subjects whose PPD induration is \>=5 mm but \<10 mm are eligible for the study if they have a negative chest X-ray during the screening period.
•Fever (body temperature \>38°C) or symptomatic viral infection or bacterial infection within 2 weeks prior to Day
•Receipt of live vaccine within 4 weeks prior to Day

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapy

Secondary Outcomes

To assess the pharmacokinetics and pharmacodynamics of multiple doses of BG9924 in this patient population
To assess the preliminary efficacy of multiple doses of BG9924 in this patient population