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Ankylosing SpondylitisPhase 4NCT01934933

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

A Phase 4 study testing celebrex, Enbrel and Enbrel plus Celebrex in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
celebrex, Enbrel and Enbrel plus Celebrex
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
24 Sep 2014to 30 Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510630

Other trials in China

About this study

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

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.

Read the 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.

Being tested
celebrex, Enbrel, Enbrel plus Celebrex
Keywords
inflammation, etanercept, celecoxib, ankylsoing spondylitis
Medical subject headings
Spondylitis, Ankylosing, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • celebrexDrug

    Also called celecoxib

  • EnbrelDrug

    Also called etanercept

  • Enbrel plus CelebrexDrug

    Also called celecoxib plus etanercept

Study groups in NCT01934933
Study groupRoleWhat they receive
celebrexActive comparatorcelebrex capsule, 0.2 gram bid, 52 weeks
Receives: Drug: celebrex
EnbrelActive comparatoretanercept injection, 25mg per injection, 50mg/week, 52 weeks
Receives: Drug: Enbrel
Enbrel plus CelebrexActive comparator50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks
Receives: Drug: Enbrel plus Celebrex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the SPARCC score of spine and SI joint

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

    Measured: 52th weeks

  2. ASAS20 response rate

    ASAS20 response rate on 52th week

    Measured: 52th week

Secondary outcomes (5)

  1. ASAS40 response rate

    ASAS40 response rate on 52th week

    Measured: 52th week

  2. ASAS70 response

    ASAS70 response rate on 52th week

    Measured: 52th week

  3. ASDAS

    ASDAS major improvement ASDAS clinically important improvement on 52th week

    Measured: 52th week

  4. mSASSS score of spine

    the mSASSS score of spine on 52th week

    Measured: 52th week

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

    the MRI SPARCC SSS score of spine on 52th week

    Measured: 52th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2013 (estimated)
  2. Study start24 Sep 2014
  3. Primary completion23 Sep 2015
  4. Study completion30 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01934933
Sponsor's protocol ID
[2013]2-93
Status last verified
Jun 2018
First submitted
17 Aug 2013
Last updated
18 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36091030

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing celebrex, Enbrel and Enbrel plus Celebrex in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the SPARCC score of spine and SI joint (time frame: 52th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01934933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.

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