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Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

NCT00844142 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-02-13

No results posted yet for this study

Summary

Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.

Conditions

  • Moderate to Severe Active Axial Spondyloarthritis

Interventions

DRUG

Etanercept 25mg

patients will receive etanercept 25mg twice weekly

DRUG

Sulfasalazine

in this arm patients will receive sulfasalazine 2000- 3000mg per os daily

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Joachim Sieper, MD · Charite, Campus Benjamin-Franklin, Rheumatology, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00844142 on ClinicalTrials.gov