Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934933
• Other study ID #: [2013]2-93
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2014
• Est. completion date: January 30, 2017

Study information

• Verified date: June 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

Description:

A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP＞6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 30, 2017
• Est. primary completion date: September 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years

• Meet 1984 NewYork modified criteria for AS

• BASDAI=4 or ASDAS score = 2.1

• CRP>6 mg/L or ESR>28 mm/h

• Syndesmophyte quantity =2 and <16 of spine

• Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception

• No active or latent tuberculosis infection.

Exclusion Criteria:

• Pregnant or breastfeeding women

• current or previous history of psoriasis or inflammatory bowel disease.

• infection with clinical significance within 24 weeks before screening

• receipt any bio-agents treatment within 12 weeks before screening

• corticosteroids intra-articular injections in last 3 months before the trial

• Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.

• Alcohol and drug abuse

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• celebrex

• Enbrel

• Enbrel plus Celebrex

Locations

Country	Name	City	State
China	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the SPARCC score of spine and SI joint	the MRI SPARCC score of spine and SI joint on 52th week	52th weeks
Primary	ASAS20 response rate	ASAS20 response rate on 52th week	52th week
Secondary	ASAS40 response rate	ASAS40 response rate on 52th week	52th week
Secondary	ASAS70 response	ASAS70 response rate on 52th week	52th week
Secondary	ASDAS	ASDAS major improvement ASDAS clinically important improvement on 52th week	52th week
Secondary	mSASSS score of spine	the mSASSS score of spine on 52th week	52th week
Secondary	Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)	the MRI SPARCC SSS score of spine on 52th week	52th week