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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292422
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : December 31, 2007
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BG9924 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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Primary Outcome Measures :
  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 Outcome Measures :
  1. To assess the pharmacokinetics and pharmacodynamics of multiple doses of BG9924 in this patient population
  2. To assess the preliminary efficacy of multiple doses of BG9924 in this patient population

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.

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 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.
  • If the subject has previously received cell-depleting therapies, relevant cell counts must have returned to normal.
  • Subjects will be excluded who meet any of the following criteria regarding treatment with concomitant therapy for RA:

    • Concomitant use of an oral steroid exceeding 10 mg/day of prednisone (or equivalent dose) or, if 10 mg/day or less, was not administered at a stable dose for at least 4 weeks prior to Day 0.
    • Concomitant use of an NSAID that was not administered at a stable dose for at least 2 weeks prior to Day 0.
    • Concomitant use of hydroxychloroquine sulfate at >400 mg/day or not administered at a stable dose for 4 weeks prior to Day 0.
    • Concomitant use of other anti-arthritic treatments, including approved or experimental oral or topical agents, within 4 weeks prior to Day 0.
    • Intra-articular corticosteroid injections within 4 weeks prior to Day 0.
    • Previous exposure to BG9924.
  • Subjects will be excluded who underwent any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 12 weeks prior to baseline or who are planning such a procedure within 16 weeks after randomization.
  • Subjects with any laboratory test result at Screening considered clinically significant (as determined by the Investigator) or

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) established by the central laboratory
    • Platelet count <150,000/μL
    • Hemoglobin <8.5 g/dL
    • Neutrophil count <1.5-10^3/μL
  • Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV; it is recognized that HIV testing may not be permitted at all sites).
  • Nursing mother, pregnant women and women who are planning to become pregnant while in the study.
  • Blood donation (1 unit or more) within 1 month prior to screening.
  • History of drug or alcohol abuse (as determined by the Investigator) within 1 year prior to Day 0.
  • Current enrollment in any other investigational drug study.
  • Previous participation in this study.
  • Subjects who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator/Sponsor for any other reason.
  • Other unspecified reasons that, in the opinion of the Investigator/Sponsor, make the subject unsuitable for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292422

United States, Michigan
Fiechtner Research Inc.
Lansing, Michigan, United States, 48910
United States, Missouri
Arthritis Consultants Inc.
St. Louis, Missouri, United States, 63141
United States, Pennsylvania
The Arthritis Group
Philadelphia, Pennsylvania, United States, 19152
Centrum Medyczne SpecjalistycznyGabinet Lekarski
Bialystok, Poland, 15-337
Oddzial Reumatologii Wojewodzki Szpital
Elblag, Poland, 82-300
Osrodek Badan Klinicznych
Lublin, Poland, 20-022
Prakyta Lekarza Rodzinnego "Nasz Lekarz"
Torun, Poland, 87-100
Klinika Chorob Tkanki Lacznej-Instytut Reumatologiczny
Warsawa, Poland, 02-637
Klinika Reumatologii-Instytut Reumatologiczny
Warsawa, Poland, 02-637
Centrum Leczenia Chorob Cywilizacyjnych
Warsawa, Poland, 02-777
Sponsors and Collaborators
Study Director: Evan Beckman, MD Biogen

Responsible Party: Biogen Idec Medical Director, Biogen Idec Inc. Identifier: NCT00292422     History of Changes
Other Study ID Numbers: 104-RA-201
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: December 31, 2007
Last Verified: December 2007

Keywords provided by Biogen:
Arthritis, Rheumatoid
Antirheumatic Agents

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors