Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis

NCT00292422 | Completed Phase 2

• 1 other identifier: 104-RA-201
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 10

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.

Conditions

Rheumatoid Arthritis

Keywords

Arthritis, Rheumatoid; Methotrexate; Antirheumatic Agents

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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

Interventions

BG9924 DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0.
• 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• All DMARDs, other than MTX or hydroxychloroquine sulfate, must be withdrawn at least 4 weeks prior to Day 0 (8 weeks for infliximab, adalimumab, and leflunomide).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.

You may not qualify if:

• 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 0.
• 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 0.
• Receipt of live vaccine within 4 weeks prior to Day 0.
• Clinically significant chest X-ray abnormality within 3 months prior to Screening.
• Current or prior treatment with more than 1 anti-TNF agent (etanercept, infliximab, or adalimumab) or other approved or investigational biologic agent for the treatment of RA.
• Previous treatment with an anti-a4 integrin antibody within the last 6 months.
• Anti-TNF therapy with infliximab or adalimumab within 8 weeks or etanercept within 4 weeks prior to Day 0.
• Treatment with another investigational drug within the 3 months prior to Day 0 or within 5 half-lives of the agent, which ever is longer.

Sponsors & Collaborators

• Biogen: lead

Study Sites (10)

Fiechtner Research Inc.

Lansing, Michigan, 48910, United States

Location

Arthritis Consultants Inc.

St Louis, Missouri, 63141, United States

Location

The Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Centrum Medyczne SpecjalistycznyGabinet Lekarski

Bialystok, 15-337, Poland

Location

Oddzial Reumatologii Wojewodzki Szpital

Elblag, 82-300, Poland

Location

Osrodek Badan Klinicznych

Lublin, 20-022, Poland

Location

Prakyta Lekarza Rodzinnego "Nasz Lekarz"

Torun, 87-100, Poland

Location

Klinika Chorob Tkanki Lacznej-Instytut Reumatologiczny

Warsaw, 02-637, Poland

Location

Klinika Reumatologii-Instytut Reumatologiczny

Warsaw, 02-637, Poland

Location

Centrum Leczenia Chorob Cywilizacyjnych

Warsaw, 02-777, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Evan Beckman, MD

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: November 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: December 31, 2007

Record last verified: 2007-12

Locations

PL (7); US (3)