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Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

etanercept

sulphasalazine (SSZ)

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis (AS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of ankylosing spondylitis Active ankylosing spondylitis Exclusion Criteria: Complete ankylosis of spine Previous treatment with etanercept

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT00247962

First Posted

October 31, 2005

Last Updated

October 9, 2012

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00247962

Brief Title

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Official Title

A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis (AS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

566 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

etanercept

Intervention Description

50 mg

Intervention Type

Drug

Intervention Name(s)

sulphasalazine (SSZ)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)

Description

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline

Description

Time Frame

Baseline and 16 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of ankylosing spondylitis Active ankylosing spondylitis Exclusion Criteria: Complete ankylosis of spine Previous treatment with etanercept

Overall Study Officials: