Ankylosing Spondylitis Clinical Trial
— COMARISOfficial title:
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
Status | Completed |
Enrollment | 110 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject 18 years of age or older - Able and willing to give written informed consent and to comply with the requirements of the study protocol - Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria - Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs Exclusion Criteria: - Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy. - Previous methotrexate treatment, not stopped 3 month before inclusion - Surgery scheduled during study - Female subject without method of contraception - Contraindication to adalimumab or methotrexate |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Rhumatologie, CH de BLOIS | Blois | |
France | Rhumatologie, CHRU de BREST | Brest | |
France | Rhumatologie, CHD LA ROCHE SUR YON | La Roche Sur Yon | |
France | Rhumatologie, CHR du MANS | Le Mans | |
France | Rhumatologie, CHRU de NANTES | Nantes | |
France | Rhumatologie / IPROS, CHR d'ORLEANS | Orleans | |
France | Rhumatologie, CHRU de POITIERS | Poitiers | |
France | Rhumatologie, CHRU de RENNES | Rennes | |
France | Rhumatologie, CH de SAINT BRIEUC | Saint Brieuc | |
France | Médecine polyvalente, CH de SAINT NAZAIRE | Saint Nazaire | |
France | Rhumatologie, CHRU de TOURS | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence or absence of antibodies against adalimumab | 6 months | No | |
Secondary | Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 6 months | No | |
Secondary | Change from baseline of T and B cells concentrations. | 6 months | Yes | |
Secondary | Change from baseline of "APRIL" and "TNF alpha" concentrations | 6 months | No |
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 |
NCT02758782 -
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis
|
Phase 4 | |
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 |
NCT00715091 -
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
|
Phase 4 | |
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 | |
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 |