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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00000433
Date of registration:	18/01/2000
Prospective Registration:	No
Primary sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Public title:	Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
Scientific title:	Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis
Date of first enrolment:	October 1999
Target sample size:	42
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00000433
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment
United States

Contacts

Name:	John C. Davis, MD, MPH
Address:
Telephone:
Email:
Affiliation:	Division of Rheumatology, University of California - San Francisco Department of Medicine

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: Anti-Tumor Necrosis Factor

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

NIAMS-043

N01 AR92244

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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