NCT02638896

Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhixiang Huang · Other Government
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.

Detailed description

This single-centre, open-labeled randomized study will evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in patients who achieved a significant clinical response. AS patients who meet the inclusion criteria will take celecoxib (0.4g/d) during the whole period of study. In the first period, all patients will be given etanercept 50 mg subcutaneous injections weekly from baseline to week12. In the second period, patients who satisfied the criteria for disease remission will be randomized to one of the following three treatment arms: (1) Dose reduction arm: Patients will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. (2) Dose maintenance arm: Etanercept remains unchange from week12 to week24. (3) Etanercept discontinuation arm: Patients will be treated with sulfasalazine (2g/d) oral administration till week24. In the third period, all patients will take sulfasalazine (2g/d) till week 48. Ankylosing spondylitis disease activity score (ASDAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metrology index (BASMI),Spondyloarthritis research consortium of Canada(SPARCC) score for the sacroiliac joint and adverse effect will be assessed in the study.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	etanercept (Half-Dose)	AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .
DRUG	etanercept (Full-Dose)	AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.
DRUG	Sulfasalazine	AS patients who satisfied the criteria for disease remission (ASDAS\<1.3) will take sulfasalazine (2g/d) from week12 to week48.
DRUG	Celecoxib	Celecoxib (0.4g/d) will be the background therapy.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2015-12-23
• Last updated: 2015-12-28