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

NCT01934933 | Completed Phase 4 DMC

• 1 other identifier: [2013]2-93
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

inflammation; etanercept; celecoxib; ankylsoing spondylitis

Outcome Measures

Primary Outcomes (2)

• the SPARCC score of spine and SI joint

  the MRI SPARCC score of spine and SI joint on 52th week

  52th weeks

• ASAS20 response rate

  ASAS20 response rate on 52th week

  52th week

Secondary Outcomes (5)

• ASAS40 response rate

  52th week

• ASAS70 response

  52th week

• ASDAS

  52th week

• mSASSS score of spine

  52th week

• Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)

  52th week

Study Arms (3)

celebrex

ACTIVE COMPARATOR

celebrex capsule, 0.2 gram bid, 52 weeks

Drug: celebrex

Enbrel

ACTIVE COMPARATOR

etanercept injection, 25mg per injection, 50mg/week, 52 weeks

Drug: Enbrel

Enbrel plus Celebrex

ACTIVE COMPARATOR

50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks

Drug: Enbrel plus Celebrex

Interventions

celebrex DRUG

Also known as: celecoxib

celebrex

Enbrel DRUG

Also known as: etanercept

Enbrel

Enbrel plus Celebrex DRUG

Also known as: celecoxib plus etanercept

Enbrel plus Celebrex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (1)

• Tu L, Zhao M, Wang X, Kong Q, Chen Z, Wei Q, Li Q, Yu Q, Ye Z, Cao S, Lin Z, Liao Z, Lv Q, Qi J, Jin O, Pan Y, Gu J. Etanercept/celecoxib on improving MRI inflammation of active ankylosing spondylitis: A multicenter, open-label, randomized clinical trial. Front Immunol. 2022 Aug 26;13:967658. doi: 10.3389/fimmu.2022.967658. eCollection 2022.

  PMID: 36091030 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Inflammation

Interventions

Celecoxib; Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Jieruo Gu, Prof

  Department of Rheumatology ,Third Affiliated Hospital of Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: August 17, 2013
• First Posted: September 4, 2013
• Study Start: September 24, 2014
• Primary Completion: September 23, 2015
• Study Completion: January 30, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

CN (1)