Blocking Tumor Necrosis Factor in Ankylosing Spondylitis

NCT00000433 | Completed Phase 2

• 2 other identifiers: N01 AR92244NIAMS-043
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylitis, Ankylosing

Keywords

Spondylitis; Etanercept; ENBREL; Tumor necrosis factor-alpha

Interventions

Anti-Tumor Necrosis Factor DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

UCSF-Clinical Trials Center

San Francisco, California, 94143-0792, United States

Location

Related Publications (3)

• Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med. 2002 May 2;346(18):1349-56. doi: 10.1056/NEJMoa012664.

  PMID: 11986408 BACKGROUND

• Davis JC Jr, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, Kivitz A, Fleischmann R, Inman R, Tsuji W; Enbrel Ankylosing Spondylitis Study Group. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum. 2003 Nov;48(11):3230-6. doi: 10.1002/art.11325.

  PMID: 14613288 BACKGROUND

• Davis JC Jr, Huang F, Maksymowych W. New therapies for ankylosing spondylitis: etanercept, thalidomide, and pamidronate. Rheum Dis Clin North Am. 2003 Aug;29(3):481-94, viii. doi: 10.1016/s0889-857x(03)00028-0.

  PMID: 12951863 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylitis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Bone Diseases, Infectious; Infections

Study Officials

• John C. Davis, MD, MPH

  Division of Rheumatology, University of California - San Francisco Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: October 1, 1999
• Study Completion: March 1, 2002
• Last Updated: January 4, 2007

Record last verified: 2003-02

Locations

US (1)