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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895764
First Posted: July 10, 2013
Last Update Posted: September 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Tours
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 6 months ]
  • Change from baseline of T and B cells concentrations. [ Time Frame: 6 months ]
  • Change from baseline of "APRIL" and "TNF alpha" concentrations [ Time Frame: 6 months ]

Enrollment: 110
Study Start Date: March 2013
Study Completion Date: April 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01895764     History of Changes
Other Study ID Numbers: PHRI12-ED-COMARIS
2012-004939-23 ( EudraCT Number )
A130042-32 ( Other Identifier: ANSM )
2012-R41 ( Other Identifier: CPP )
First Submitted: April 24, 2013
First Posted: July 10, 2013
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Tours:
ankylosing spondylitis

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