The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
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
presence or absence of antibodies against adalimumab
Time frame: 6 months
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
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Le Mans, France
Rhumatologie, CHRU de NANTES
Nantes, France
Rhumatologie / IPROS, CHR d'ORLEANS
Orléans, 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
...and 1 more locations