Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01895764
First received: April 24, 2013
Last updated: April 8, 2015
Last verified: April 2015
  Purpose

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Adalimumab
Drug: Methotrexate
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: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • presence or absence of antibodies against adalimumab [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline of T and B cells concentrations. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline of "APRIL" and "TNF alpha" concentrations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab
adalimumab 40mg every 2 weeks
Drug: Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Other Name: Humira
Experimental: Adalimumab + Methotrexate
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
Drug: Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Other Name: Humira
Drug: Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Other Name: Metoject

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01895764

Locations
France
Rhumatologie, CH de BLOIS
Blois, France, 41000
Rhumatologie, CHRU de BREST
Brest, France, 29609
Rhumatologie, CHD LA ROCHE SUR YON
La Roche Sur Yon, France, 85925
Rhumatologie, CHR du MANS
Le Mans, France, 72037
Rhumatologie, CHRU de NANTES
Nantes, France, 44093
Rhumatologie / IPROS, CHR d'ORLEANS
Orleans, France, 45032
Rhumatologie, CHRU de POITIERS
Poitiers, France, 86021
Rhumatologie, CHRU de RENNES
Rennes, France, 35203
Rhumatologie, CH de SAINT BRIEUC
Saint Brieuc, France, 22027
Médecine polyvalente, CH de SAINT NAZAIRE
Saint Nazaire, France, 44606
Rhumatologie, CHRU de TOURS
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Emilie DUCOURAU, MD CHRU de TOURS
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01895764     History of Changes
Other Study ID Numbers: PHRI12-ED-COMARIS, 2012-004939-23, A130042-32, 2012-R41
Study First Received: April 24, 2013
Last Updated: April 8, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
ankylosing spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Adalimumab
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2015