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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00247962
Other study ID # 0881A3-402
Secondary ID
Status Completed
Phase Phase 4
First received October 31, 2005
Last updated October 9, 2012
Start date December 2005
Est. completion date February 2008

Study information

Verified date October 2012
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.


Recruitment information / eligibility

Status Completed
Enrollment 566
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of ankylosing spondylitis

- Active ankylosing spondylitis

Exclusion Criteria:

- Complete ankylosis of spine

- Previous treatment with etanercept

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
etanercept
50 mg
sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Australia,  Austria,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Poland,  Qatar,  Saudi Arabia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement = 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for = 3 domains, and no worsening in remaining domain. 16 weeks No
Secondary Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL). Baseline and 16 Weeks Yes
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