Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02758782
Other study ID # CONSUL2016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2016
Est. completion date January 2021

Study information

Verified date January 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 spondylitis (AS).


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).


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
Golimumab

Drug:
Celecoxib


Locations

Country Name City State
Germany Rheumapraxis Kupka Altenburg
Germany Rheumapraxis Bayreuth Dr. Ochs Bayreuth
Germany Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte Berlin
Germany Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Benjamin Franklin Berlin
Germany MVZ Drs. Mielke Berlin
Germany Rheumapraxis Dr. Zinke Berlin
Germany Rheumatologische Praxis Dr. Karberg/Brandt Berlin
Germany Rheumatologische Schwerpunktpraxis Berlin
Germany Schlossparkklinik, Dpt. of Rheumatologie Berlin
Germany Rheumatologische Schwerpunktpraxis an den Kreiskliniken Burghausen
Germany Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (CIRI) Frankfurt / Main
Germany Praxis Dr Kühne Haldensleben I
Germany Medizinische Hochschule, Rheumatologie Hannover
Germany Rheumazentrum Ruhrgebiet Herne
Germany Universitätsklinikum Köln, Rheumatologie Koeln
Germany Rheumapraxis Magdeburg Magdeburg
Germany Klinikum Rechts der ISAR (TU München) München
Germany Rheumapraxis Dr. Jacki Tübingen
Germany University of Tuebingen, Dpt. Rheumatology Tübingen

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 thera — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
Secondary New syndesmophyte formation or progression of existing syndesmophytes New syndesmophyte formation or progression of existing syndesmophytes 2 years
Secondary Improvement of disease activity (BASDAI) Improvement of disease activity (BASDAI) 2 years
Secondary Improvement of disease activity (ASDAS) Improvement of disease activity (ASDAS) 2 years
Secondary Improvement of function (BASFI) Improvement of function (BASFI) 2 years
Secondary Improvement of axial mobility (BASMI) Improvement of axial mobility (BASMI) 2 years
Secondary Improvement of quality of life measures (ASAS Health Index) Improvement of quality of life measures (ASAS Health Index) 2 years
Secondary 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 2 years
Secondary Change of Berlin MRI score (SUBSTUDY) Change of Berlin MRI score (SUBSTUDY) 2 years
Secondary 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 2 years
See also
  Status Clinical Trial Phase
Terminated NCT02685904 - A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis Phase 3
Completed NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT01668004 - The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Phase 4
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
Not yet recruiting NCT04875299 - Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Completed NCT02763111 - Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis Phase 2
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT01463189 - Web-based Support to Manage Arthritis Pain Phase 2
Completed NCT01091675 - Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Phase 3
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Completed NCT00715091 - Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase 4
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00367211 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. Phase 3
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4
Active, not recruiting NCT00243750 - Methotrexate in Ankylosing Spondylitis (MTX in AS) Phase 2