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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Enbrel (etanercept)

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main inclusion criteria

Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
18 to 70 years of age.

Main exclusion criteria

Complete ankylosis (fusion) of spine.
Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors.
Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.

Sites / Locations

Outcomes

Primary Outcome Measures

To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the

percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.

Secondary Outcome Measures

To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept

compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.

Full Information

NCT ID

NCT00421915

First Posted

January 8, 2007

Last Updated

January 12, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00421915

Brief Title

Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Official Title

Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.

6. Conditions and Keywords

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

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

84 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Enbrel (etanercept)

Primary Outcome Measure Information:

Title

To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the

Title

percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.

Secondary Outcome Measure Information:

Title

To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept

Title

compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main inclusion criteria Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis). Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100). 18 to 70 years of age. Main exclusion criteria Complete ankylosis (fusion) of spine. Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors. Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

30473179

Citation

Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.

Results Reference

derived

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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

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