Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934933
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: celebrex Drug: Enbrel Drug: Enbrel plus Celebrex Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2014
Actual Primary Completion Date : September 23, 2015
Actual Study Completion Date : January 30, 2017


Arm Intervention/treatment
Active Comparator: celebrex
celebrex capsule, 0.2 gram bid, 52 weeks
Drug: celebrex
Other Name: celecoxib

Active Comparator: Enbrel
etanercept injection, 25mg per injection, 50mg/week, 52 weeks
Drug: Enbrel
Other Name: etanercept

Active Comparator: Enbrel plus Celebrex
50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks
Drug: Enbrel plus Celebrex
Other Name: celecoxib plus etanercept




Primary Outcome Measures :
  1. the SPARCC score of spine and SI joint [ Time Frame: 52th weeks ]
    the MRI SPARCC score of spine and SI joint on 52th week

  2. ASAS20 response rate [ Time Frame: 52th week ]
    ASAS20 response rate on 52th week


Secondary Outcome Measures :
  1. ASAS40 response rate [ Time Frame: 52th week ]
    ASAS40 response rate on 52th week

  2. ASAS70 response [ Time Frame: 52th week ]
    ASAS70 response rate on 52th week

  3. ASDAS [ Time Frame: 52th week ]
    ASDAS major improvement ASDAS clinically important improvement on 52th week

  4. mSASSS score of spine [ Time Frame: 52th week ]
    the mSASSS score of spine on 52th week

  5. Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS) [ Time Frame: 52th week ]
    the MRI SPARCC SSS score of spine on 52th week



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934933


Locations
Layout table for location information
China, Guangdong
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Study Director: Jieruo Gu, Prof Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University

Layout table for additonal information
Responsible Party: Gu Jieruo, Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01934933     History of Changes
Other Study ID Numbers: [2013]2-93
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Gu Jieruo, Sun Yat-sen University:
inflammation
etanercept
celecoxib
ankylsoing spondylitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors