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Ankylosing SpondylitisPhase 4CONSULNCT02758782

NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis

A Phase 4 study testing Golimumab and Celecoxib in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 19 sites in Germany.

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

To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) - Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with ankylosing… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Golimumab and Celecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
19 sitesGermany
Study dates
Sep 2016to Jan 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Major Inclusion Criteria:

  • Definite diagnosis of AS according to the "modified New York criteria".
  • History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each.
  • Active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) value of ≥4 at screening.
  • Presence of at least one of the following risk factors for radiographic spinal progression:
  1. Elevated C reactive protein (CRP; >5mg/l) at screening at the absence of reasons for elevated CRP other than AS;
  2. Presence of ≥ 1 syndesmophyte on prior X-rays of the spine.
  • Subject is a candidate for anti-TNF therapy based on the Investigator's opinion.
  • Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.
  • If female: either unable to bear children (postmenopausal for at least 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study and 6 months after

Inclusion Criterion for Phase II (randomized part of the study):

  • adequate response to Golimumab during Phase I (referred to as decline in BASDAI)

Major Exclusion Criteria:

  • For female subjects: pregnancy or lactating
  • subjects with chronic inflammatory articular disease other than spondyloarthritis / AS or systemic autoimmune disease, e.g. systemic lupus erythematosus, Sjögren´s syndrome, rheumatoid arthritis.
  • history of inadequate response to anti-TNF-therapy
  • intolerability/hypersensitivity to one of the drugs or other components of the study medication
  • presence ot total spinal ankylosis
  • contraindications to anti-TNF-therapy (current or remitting clinical significant infections, tuberculosis, viral hepatitis, HIV; malignancies; demyelinating disease; vaccination with live vaccine within 3 months before, during and until 6 months after study)
  • (relative) contraindications to Celecoxib therapy (uncontrolled arterial hypertension, high cardiovascular risk / history of cardiovascular events; history of gastrointestinal ulcers or relevant bleeding; known M. Crohn or ulcerative colitis)
  • diagnosis of fibromyalgia
  • significant lab abnormalities

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Rheumapraxis Kupka

    Altenburg, 04600

  • Rheumapraxis Bayreuth Dr. Ochs

    Bayreuth, 95444

  • Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte

    Berlin, 10117

  • Rheumatologische Schwerpunktpraxis

    Berlin, 12161

  • Rheumatologische Praxis Dr. Karberg/Brandt

    Berlin, 12163

  • Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Benjamin Franklin

    Berlin, 12200

  • MVZ Drs. Mielke

    Berlin, 12627

  • Rheumapraxis Dr. Zinke

    Berlin, 13055

  • Schlossparkklinik, Dpt. of Rheumatologie

    Berlin, 14059

  • Rheumatologische Schwerpunktpraxis an den Kreiskliniken

    Burghausen, 84489

  • Universitätsklinikum Köln, Rheumatologie

    Cologne, 50937

  • Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (CIRI)

    Frankfurt am Main, 60528

  • Praxis Dr Kühne

    Haldensleben I, 39340

  • Medizinische Hochschule, Rheumatologie

    Hanover, 30625

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Rheumapraxis Magdeburg

    Magdeburg, 39104

  • Klinikum Rechts der ISAR (TU München)

    München, 81675

  • Rheumapraxis Dr. Jacki

    Tübingen, 72072

  • University of Tuebingen, Dpt. Rheumatology

    Tübingen, 72076

Other trials in Germany

About this study

Official title: COmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre Trial

To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) - Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS).

Read the detailed description

The aim of the proposed trial is to evaluate the efficacy of combined treatment with a non-steroidal anti-inflammatory drug (NSAID) added to anti-tumour necrosis factor (TNF) therapy as compared to anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS). The trial consists of two phases. In the phase I (run-in phase), patients with active AS despite treatment with NSAIDs and elevated C-reactive protein will be included and treated with a TNF blocker (golimumab). Patients with good clinical response to golimumab at week 12 will be eligible for the phase II (core phase) of the study and will be randomized 1:1 to 1) golimumab + celecoxib (experimental intervention) for 2 years (weeks 12-108) or 2) golimumab alone (control intervention) also for 2 years. The primary outcome parameter will be the absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) - currently a standard of structural spinal damage progression evaluation in AS - over two years of therapy (weeks 12-108).

Being tested
Golimumab, Celecoxib
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • GolimumabBiological

    Also called Simponi

  • CelecoxibDrug

    Also called Celebrex

Study groups in NCT02758782
Study groupRoleWhat they receive
Golimumab monotherapyActive comparatorTreatment with 50 mg Golimumab subcutaneous once monthly
Receives: Biological: Golimumab
Golimumab combined with CelecoxibActive comparatorTreatment with Golimumab 50 mg subcutaneous once monthly in combination with Celecoxib 400 mg orally every day
Receives: Biological: Golimumab; Drug: Celecoxib

What is being measured

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

  1. Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial

    Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial

    Measured: 2 years

Secondary outcomes (9)

  1. New syndesmophyte formation or progression of existing syndesmophytes

    New syndesmophyte formation or progression of existing syndesmophytes

    Measured: 2 years

  2. Improvement of disease activity (BASDAI)

    Improvement of disease activity (BASDAI)

    Measured: 2 years

  3. Improvement of disease activity (ASDAS)

    Improvement of disease activity (ASDAS)

    Measured: 2 years

  4. Improvement of function (BASFI)

    Improvement of function (BASFI)

    Measured: 2 years

  5. Improvement of axial mobility (BASMI)

    Improvement of axial mobility (BASMI)

    Measured: 2 years

  6. Improvement of quality of life measures (ASAS Health Index)

    Improvement of quality of life measures (ASAS Health Index)

    Measured: 2 years

  7. Change of the enteric microbiome profile at week 108 in comparison to baseline

    Change of the enteric microbiome profile at week 108 in comparison to baseline

    Measured: 2 years

  8. Change of Berlin MRI score (SUBSTUDY)

    Change of Berlin MRI score (SUBSTUDY)

    Measured: 2 years

  9. Adverse events (AE), serious AE and AE of interest until end of study

    Adverse events (AE), serious AE and AE of interest until end of study

    Measured: 2 years

Timeline

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

  1. First posted2 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2021
  4. Study completionJan 2021

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
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758782
Sponsor's protocol ID
CONSUL2016
Acronym
CONSUL
Status last verified
Jan 2021
First submitted
20 Apr 2016
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Proft F, Muche B, Listing J, Rios-Rodriguez V, Sieper J, Poddubnyy D. Study protocol: COmparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis (CONSUL) - an open-label randomized controlled multicenter trial. BMJ Open. 2017 Jun 10;7(6):e014591. doi: 10.1136/bmjopen-2016-014591.

    PubMed 28601821

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Golimumab and Celecoxib in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 19 sites in Germany.

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

Who may be eligible to take part?

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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. 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?

Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial (time frame: 2 years). 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 NCT02758782, 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 27 Jan 2021.

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