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The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate.
Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups:
Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo
In all treatment groups patients will continue to take a stable dose of methotrexate.
There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ALD518 80 mg |
|
| 2 | Experimental | ALD518 160 mg |
|
| 3 | Experimental | ALD518 320 mg |
|
| 4 | Placebo Comparator | No ALD518 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALD518 | Biological | Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs and SAEs during the study | During entire length of study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12 | 12 weeks after Dose 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Smith, MD, FRCP | Alder BioPharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K-W Musculoskeletal Research, Inc. | Kitchener | Ontario | N2M 5N6 | Canada | ||
| Rheumatology Research Associates |
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| Infusion without ALD518' | Biological | 250 cc Normal saline IV over one hour Weeks 1 and 8. |
|
| Ottawa |
| Ontario |
| KIH IA2 |
| Canada |
| V. Tsitlanadze Scientific Practical Centre of Rheumatology | Tbilisi | 0102 | Georgia |
| Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | 0186 | Georgia |
| Chanre Rheumatology and Immunology Center and Research | Malleshwaram | Bangalore | 560 003 | India |
| KLE Society Hospital and Medical Research Centre | Nehru Nagar | Belgaum | 590 010 | India |
| Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics | Ramadaspeth | Nagpur | 440 010 | India |
| St. John's Medical College Hospital | Bangalore | 560 034 | India |
| Krishna Institute of Medical Sciences Ltd. | Secunderabad | 500 003 | India |
| Miriada Center Private Clinic of Professor Sierakowski | Bialystok | 15-297 | Poland |
| Nonpublic Centre of Medical Care Reumed | Lublin | 26-607 | Poland |
| NOVAMED - Medical Center of Poznan | Poznan | 60-773 | Poland |
| Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko | Sopot | 81-759 | Poland |
| Szezecin Clinic of Rheumatology and Internal Diseases | Szczecin | 71-252 | Poland |
| Regional Clinical Hospital of War Veterans | Kemerovo | 650099 | Russia |
| Institute of Clinical and Experimental Lymphology | Novosibirsk | 630117 | Russia |
| Ryazan Regional Clinical Cardiologic Dispensary | Ryazan | 390026 | Russia |
| Saint Petersburg Medical Academy of Postgraduate Study | Saint Petersburg | 191015 | Russia |
| Saint-Petersburg State Medical Academy named after I. I. Mechnikov | Saint Petersburg | 195067 | Russia |
| City Hospital #26 | Saint Petersburg | 196247 | Russia |
| Regional War Veterans' Hospital | Saratov | 410002 | Russia |
| Tomsk Regional Clinical Hospital | Tomsk | 634063 | Russia |
| Tula Regional Clinical Hospital | Tula | 300053 | Russia |
| Clinical Hospital of Emergency Care named after N.V. Solovyev | Yaroslavl | 150003 | Russia |
| Institute of Rheumatology | Belgrade | 11000 | Serbia |
| Institute for Rehabilitation and Treatment Niska Banja | Niška Banja | 18205 | Serbia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604955 | clazakizumab |
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