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OpenTrials
Completed

NCT Number: NCT00664716

Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Coordinating Research Site, San Miguel de Tucumán, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Diagnosis of RA (functional class I - III)
  • Stable dose of MTX
  • Inadequate response to at least one conventional DMARD therapy

Key Exclusion Criteria:

  • Serious local infection or systemic infection
  • History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
  • Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
  • Clinical significant lab tests at screening
  • Positive for Hep C or Hep B at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Baminercept alfa 1

Biological

experimental - one dose level

Other names: BG9924, LT beta

Placebo

Biological

Placebo comparator

Other names: BG9924, LT beta

Baminercept alfa 2

Biological

experimental - second dose level

Other names: LT beta, BG9924

Baminercept alfa 3

Biological

experimental - third dose level

Other names: BG9924, LT beta

Baminercept alfa 4

Biological

experimental - fourth dose level

Other names: BG9924, LT beta

Baminercept alfa 5

Biological

experimental - fifth dose level

Other names: LT beta, BG9924

Primary outcomes

  1. Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy

    Time frame: 3 months

Secondary outcomes

  1. Assess the safety and tolerability of BG9924 in this participant population

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Acronym: RESPOND

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2008
Registry last updated
Jan 21, 2016

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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