Working… Menu
Trial record 1 of 1 for:    14613288 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Blocking Tumor Necrosis Factor in Ankylosing Spondylitis

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: NCT00000433
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : January 4, 2007
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief Summary:
The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. It blocks the action of tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid arthritis, and other inflammatory conditions. We will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: Anti-Tumor Necrosis Factor Phase 2

Detailed Description:

In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS). TNFR:Fc is an antagonist of tumor necrosis factor (TNF), a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and vasculitis, as well as other inflammatory conditions.

TNFR:Fc consists of two molecules of the extracellular portion of the p75 receptor, each consisting of 235 amino acids. The two receptors are fused to the Fc portion of human IgG1, which consists of 232 amino acids. The gene fragments encoding the truncated TNFR and the Fc portion of human IgG1 are expressed in a Chinese hamster ovary cell line.

Recent observations from animal and human studies suggest that tumor necrosis factor-alpha (TNF-alpha) may play a role in disease activity in AS and other seronegative spondyloarthropathies. This study aims to test the efficacy of TNFR:Fc used in conjunction with standard medications in the treatment of AS. We will give patients either 25mg of TNFR:Fc or placebo subcutaneously twice a week for 4 months. Outcome measures will include measures of function, pain, morning stiffness, patient global assessment, and swollen joint count, as well as safety measures.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis
Study Start Date : October 1999
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Ankylosing spondylitis
  • Acceptable stable treatments during study: oral glucocorticoids (less than or equal to 10 mg/d) and/or NSAIDs at recommended doses and/or one of the following options: methotrexate (less than or equal to 20.0 mg/week); sulfasalazine (less than or equal to 3 grams/d); azathioprine (less than or equal to 2 mg/kg/d); methotrexate and sulfasalazine combination at doses listed above; 6-mercaptopurine (less than or equal to 1.5 mg/kg/d)

Exclusion Criteria:

  • Diagnosis of psoriatic arthritis, inflammatory bowel disease, reactive arthritis, or Behýet disease
  • Significant medical problems, such as diabetes mellitus
  • History of active or recurrent infections
  • Complete ankylosis of the entire spine

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): NCT00000433

Layout table for location information
United States, California
UCSF-Clinical Trials Center
San Francisco, California, United States, 94143-0792
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Layout table for investigator information
Principal Investigator: John C. Davis, MD, MPH Division of Rheumatology, University of California - San Francisco Department of Medicine

Layout table for additonal information Identifier: NCT00000433     History of Changes
Other Study ID Numbers: N01 AR92244
First Posted: January 19, 2000    Key Record Dates
Last Update Posted: January 4, 2007
Last Verified: February 2003
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Tumor necrosis factor-alpha
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis, Ankylosing
Pathologic Processes
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases