Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004939-23 | EudraCT Number | ||
| A130042-32 | Other Identifier | ANSM | |
| 2012-R41 | Other Identifier | CPP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Active Comparator | adalimumab 40mg every 2 weeks |
|
| Adalimumab + Methotrexate | Experimental | adalimumab 40mg every 2 weeks and methotrexate 10mg per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26 |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence or absence of antibodies against adalimumab | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 6 months | |
| Change from baseline of T and B cells concentrations. | 6 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emilie DUCOURAU, MD | CHRU de TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhumatologie, CH de BLOIS | Blois | 41000 | France | |||
| Rhumatologie, CHRU de BREST |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31958280 | Result | Ducourau E, Rispens T, Samain M, Dernis E, Le Guilchard F, Andras L, Perdriger A, Lespessailles E, Martin A, Cormier G, Armingeat T, Devauchelle-Pensec V, Gervais E, Le Goff B, de Vries A, Piver E, Paintaud G, Desvignes C, Ternant D, Watier H, Goupille P, Mulleman D. Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. RMD Open. 2020 Jan;6(1):e001047. doi: 10.1136/rmdopen-2019-001047. Epub 2020 Jan 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methotrexate | Drug | methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26 |
|
|
| Change from baseline of "APRIL" and "TNF alpha" concentrations |
| 6 months |
| Brest |
| 29609 |
| France |
| Rhumatologie, CHD LA ROCHE SUR YON | La Roche-sur-Yon | 85925 | France |
| Rhumatologie, CHR du MANS | Le Mans | 72037 | France |
| Rhumatologie, CHRU de NANTES | Nantes | 44093 | France |
| Rhumatologie / IPROS, CHR d'ORLEANS | Orléans | 45032 | France |
| Rhumatologie, CHRU de POITIERS | Poitiers | 86021 | France |
| Rhumatologie, CHRU de RENNES | Rennes | 35203 | France |
| Rhumatologie, CH de SAINT BRIEUC | Saint-Brieuc | 22027 | France |
| Médecine polyvalente, CH de SAINT NAZAIRE | Saint-Nazaire | 44606 | France |
| Rhumatologie, CHRU de TOURS | Tours | 37044 | France |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided