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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02758782
Collaborator
(none)
156
Enrollment
19
Locations
2
Arms
52
Duration (Months)
8.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 spondylitis (AS).

Condition or Disease Intervention/Treatment Phase
Phase 4

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Golimumab monotherapy

Treatment with 50 mg Golimumab subcutaneous once monthly

Biological: Golimumab
Other Names:
  • Simponi

    		•
    Active Comparator: Golimumab combined with Celecoxib

    Treatment with Golimumab 50 mg subcutaneous once monthly in combination with Celecoxib 400 mg orally every day

    Biological: Golimumab
    Other Names:
  • Simponi

    • Drug: Celecoxib
    Other Names:
  • Celebrex

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [2 years]

      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

    Secondary Outcome Measures

    1. New syndesmophyte formation or progression of existing syndesmophytes [2 years]

      New syndesmophyte formation or progression of existing syndesmophytes

    2. Improvement of disease activity (BASDAI) [2 years]

      Improvement of disease activity (BASDAI)

    3. Improvement of disease activity (ASDAS) [2 years]

      Improvement of disease activity (ASDAS)

    4. Improvement of function (BASFI) [2 years]

      Improvement of function (BASFI)

    5. Improvement of axial mobility (BASMI) [2 years]

      Improvement of axial mobility (BASMI)

    6. Improvement of quality of life measures (ASAS Health Index) [2 years]

      Improvement of quality of life measures (ASAS Health Index)

    7. Change of the enteric microbiome profile at week 108 in comparison to baseline [2 years]

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

    8. Change of Berlin MRI score (SUBSTUDY) [2 years]

      Change of Berlin MRI score (SUBSTUDY)

    9. Adverse events (AE), serious AE and AE of interest until end of study [2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumapraxis Kupka Altenburg Germany 04600
    2 Rheumapraxis Bayreuth Dr. Ochs Bayreuth Germany 95444
    3 Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte Berlin Germany 10117
    4 Rheumatologische Schwerpunktpraxis Berlin Germany 12161
    5 Rheumatologische Praxis Dr. Karberg/Brandt Berlin Germany 12163
    6 Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Benjamin Franklin Berlin Germany 12200
    7 MVZ Drs. Mielke Berlin Germany 12627
    8 Rheumapraxis Dr. Zinke Berlin Germany 13055
    9 Schlossparkklinik, Dpt. of Rheumatologie Berlin Germany 14059
    10 Rheumatologische Schwerpunktpraxis an den Kreiskliniken Burghausen Germany 84489
    11 Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (CIRI) Frankfurt / Main Germany 60528
    12 Praxis Dr Kühne Haldensleben I Germany 39340
    13 Medizinische Hochschule, Rheumatologie Hannover Germany 30625
    14 Rheumazentrum Ruhrgebiet Herne Germany 44649
    15 Universitätsklinikum Köln, Rheumatologie Koeln Germany 50937
    16 Rheumapraxis Magdeburg Magdeburg Germany 39104
    17 Klinikum Rechts der ISAR (TU München) München Germany 81675
    18 Rheumapraxis Dr. Jacki Tübingen Germany 72072
    19 University of Tuebingen, Dpt. Rheumatology Tübingen Germany 72076

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Denis Poddubnyy, Prof. Dr., Head of Dpt. for Rheumatology at Charite, Campus Benjamin Franklin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Denis Poddubnyy, Prof Dr Denis Poddubnyy, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02758782
    Other Study ID Numbers:
    • CONSUL2016
    First Posted:
    May 2, 2016
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Spondylitis, Ankylosing
    Celecoxib
    Golimumab

    Study Results

    No Results Posted as of Jan 27, 2021