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The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy and safety rate of the study drug, Remicade, in decreasing symptoms and signs of AS (pain) as well as the evaluation of the safety and the tolerance of the profile of the drug. | The patient undergoes the complex evaluation of the articular status every 6 -8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of achievement of at least 50% ASAS improvement (compared to baseline) 8 weeks after the last infusion of Remicade. | 8 weeks after the last infusion of Remicade | |
| Frequency of at least 50% of the stable improvement of ASAS (compared to baseline) over a period of the supportive treatment phase (after infusion 3, up to 6 to 8 weeks after the last infusion of Remicade) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21341463 | Result | Bunchuk NV, Rumiantseva OA, Loginova EIu, Bochkova AG, Storozhakov GI, Ettinger OA, Kosiura SD, Kamalova RG, Valishina LM. [The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study]. Ter Arkh. 2010;82(10):41-6. Russian. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Up to 8 weeks after the last infusion of Remicade |
| Frequency of at least 20%, 50%, and 75% of ASAS improvement (compared to baseline) 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change in AS activity (BASDAI) compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of global evaluation of the activity of the disease by patient (VAS) compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of the functional status of the patients (BASFI) compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of spine motion compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of spinal pain compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of sensation of fatigue compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS) | Up to 8 weeks after the last infusion of Remicade |
| Change of pain in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS) | Up to 8 weeks after the last infusion of Remicade |
| Change of the duration of the morning stiffness in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS) | Up to 8 weeks after the last infusion of Remicade |
| Change of the number of tender joints compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of the number of inflamed joints compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of the number of the transformed enthesitises compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of the duration of the morning spinal stiffness compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Change of serum C-reactive protein and ESR compared to baseline 6 to 8 weeks after the last infusion of Remicade | Up to 8 weeks after the last infusion of Remicade |
| Quality of life evaluation in accordance with SF-36 | 6-8 weeks after visit 10 (before the last infusion of Remicade) or in case of discontinuation |
| Obtaining of additional information on the safety profile of the tested product over a period of the study. | up to 54 weeks |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |