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

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ClinicalTrials.gov Identifier: NCT02758782
Recruitment Status : Active, not recruiting
First Posted : May 2, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Denis Poddubnyy, Charite University, Berlin, Germany

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
Ankylosing Spondylitis Biological: Golimumab Drug: Celecoxib 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).

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Study Type : Interventional  (Clinical Trial)
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 : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Golimumab monotherapy
Treatment with 50 mg Golimumab subcutaneous once monthly
Biological: Golimumab
Other Name: 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 Name: Simponi

Drug: Celecoxib
Other Name: Celebrex




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 [ Time Frame: 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 [ Time Frame: 2 years ]
    New syndesmophyte formation or progression of existing syndesmophytes

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

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

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

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

  6. Improvement of quality of life measures (ASAS Health Index) [ Time Frame: 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 [ Time Frame: 2 years ]
    Change of the enteric microbiome profile at week 108 in comparison to baseline

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02758782


Locations
Show Show 19 study locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Denis Poddubnyy, Prof. Dr. Head of Dpt. for Rheumatology at Charite, Campus Benjamin Franklin
Publications of Results:
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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    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Celecoxib
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