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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01895764
First received: April 24, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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: March 2016
Estimated Primary Completion Date: March 2016 (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

Contacts
Contact: Emilie DUCOURAU, MD 02.47.47.59.17 ext +33 emilie.ducourau@univ-tours.fr
Contact: Yoann DESVIGNES 02.47.47.46.32 ext +33 yoann.desvignes@med.univ-tours.fr

Locations
France
Rhumatologie, CH de BLOIS Recruiting
Blois, France, 41000
Principal Investigator: Fabienne LE GUILCHARD, MD         
Rhumatologie, CHRU de BREST Recruiting
Brest, France, 29609
Principal Investigator: Valérie DEVAUCHELLE, MD-PhD         
Rhumatologie, CHD LA ROCHE SUR YON Recruiting
La Roche Sur Yon, France, 85925
Principal Investigator: Grégoire CORMIER, MD         
Rhumatologie, CHR du MANS Recruiting
Le Mans, France, 72037
Principal Investigator: Emmanuelle DERNIS, MD         
Rhumatologie, CHRU de NANTES Recruiting
Nantes, France, 44093
Principal Investigator: Benoit LE GOFF, MD         
Rhumatologie / IPROS, CHR d'ORLEANS Recruiting
Orleans, France, 45032
Principal Investigator: Carine SALLIOT, MD         
Rhumatologie, CHRU de POITIERS Recruiting
Poitiers, France, 86021
Principal Investigator: Elisabeth SOLAU-GERVAIS, MD-PhD         
Rhumatologie, CHRU de RENNES Recruiting
Rennes, France, 35203
Principal Investigator: Aleth PERDRIGER, MD-PhD         
Rhumatologie, CH de SAINT BRIEUC Recruiting
Saint Brieuc, France, 22027
Principal Investigator: Antoine MARTIN, MD         
Médecine polyvalente, CH de SAINT NAZAIRE Recruiting
Saint Nazaire, France, 44606
Principal Investigator: Thomas ARMINGEAT, MD         
Rhumatologie, CHRU de TOURS Recruiting
Tours, France, 37044
Contact: Emilie DUCOURAU, MD         
Contact: Denis MULLEMAN, MD-PhD         
Principal Investigator: Denis MULLEMAN, MD-PhD         
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: February 4, 2014
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, Ankylosing
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 23, 2014