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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003843-22 | EudraCT Number |
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Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone
Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly
Follow up period - Open Label phase:
Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period. Patients who do not achieve clinical remission or patients who will experience a relapse of the disease will be treated according to standard of care (SOC) modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental |
|
|
| group B | Placebo Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab, plus prednisone | Drug | adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day |
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| subjects who maintain stable remission at 24 months; ACR 20,50,70 at month 4,8,12,24; DAS 28 at month 4,8,12,24; HAQ at week 0,4,8,12,24; radiographic progression at months 12, 24; safety of different treatment regimens | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| carlomaurizio montecucco, MD | IRCCS S. Matteo Foundation, Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS S. Matteo Hospital | Pavia | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| C407664 | deltacortene |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| adalimumab plus placebo | Drug | adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months |
|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |