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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01895764
Other study ID # PHRI12-ED-COMARIS
Secondary ID 2012-004939-23A1
Status Completed
Phase Phase 4
First received April 24, 2013
Last updated September 28, 2015
Start date March 2013
Est. completion date April 2015

Study information

Verified date September 2015
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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
See also
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