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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Denis Poddubnyy, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02758782
First received: April 20, 2016
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Ankylosing Spondylitis
Biological: Golimumab
Drug: Celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • New syndesmophyte formation or progression of existing syndesmophytes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of disease activity (BASDAI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of disease activity (ASDAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of function (BASFI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of axial mobility (BASMI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of quality of life measures (ASAS Health Index) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change of the enteric microbiome profile at week 108 in comparison to baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change of Berlin MRI score (SUBSTUDY) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adverse events (AE), serious AE and AE of interest until end of study [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: June 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02758782

Contacts
Contact: Denis Poddubnyy, Prof. Dr. +49-30-450 ext 514544 denis.poddubnyy@charite.de
Contact: Burkhard Muche, Dr. +49-30-8445 ext 4144 burkhard.muche@charite.de

Locations
Germany
Rheumapraxis Kupka
Altenburg, Germany, 04600
Rheumaambulanz Salztalklinik
Bad Soden - Salmünster, Germany, 63628
Rheumapraxis Bayreuth
Bayreuth, Germany, 95444
Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Banjamin Franklin Not yet recruiting
Berlin, Germany, 12200
Sub-Investigator: Burkhard Muche, Dr         
Sub-Investigator: Hildrun Haibel, PD Dr         
Sub-Investigator: Valeria Rios Rodriguez, Dr         
Principal Investigator: Denis Poddubnyy, Prof Dr         
Rheumatologische Schwerpunktpraxis
Berlin, Germany, 12161
Rheumatologische Praxis
Berlin, Germany, 12163
Charite Universitaetsmedicine - Dpt. Rheumatology at Campus Charite Mitte Not yet recruiting
Berlin, Germany, 10117
Contact: Burmester, Prof. Dr.         
Contact: Feist, PD Dr         
Rheumapraxis
Berlin, Germany, 12453
MVZ Drs. Mielke
Berlin, Germany, 12627
Schlossparkklinik, Rheumatologie
Berlin, Germany, 14059
Rheumatologische Schwerpunktpraxis an den Kreiskliniken
Burghausen, Germany, 84489
Kreiskrankenhaus Demmin, Rheumatologie
Demmin, Germany, 17109
Uniklinik Düsseldorf, Rheumatologie
Düsseldorf, Germany, 40225
Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (CIRI)
Frankfurt / Main, Germany, 60528
Praxis Dr Kühne
Haldensleben, Germany, 39340
Medizinische Hochschule, Rheumatologie
Hannover, Germany, 30625
Rheumazentrum Ruhrgebiet
Herne, Germany, 44649
Rheumapraxis
Magdeburg, Germany, 39104
Rheumahaus Potsdam
Potsdam, Germany, 14467
Rheumapraxis
Tübingen, Germany, 72072
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Denis Poddubnyy, Prof. Dr. Head of Dpt. for Rheumatology at Charite, Campus Benjamin Franklin
  More Information

Responsible Party: Denis Poddubnyy, Prof Dr Denis Poddubnyy, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02758782     History of Changes
Other Study ID Numbers: CONSUL2016 
Study First Received: April 20, 2016
Last Updated: April 28, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016