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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.
Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Course A1 | Experimental |
| |
| Course A2 | Placebo Comparator |
| |
| Course B | Experimental | Open-label extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alefacept | Drug | Intramuscular |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70 | 12 Weeks and at any time |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25 | Each scheduled efficacy visit | |
| Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16646026 | Background | Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. doi: 10.1002/art.21870. | |
| 19028407 | Background |
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| Methotrexate | Drug | Oral |
|
| Placebo | Drug | Intramuscular |
|
| Each scheduled efficacy visit |
| Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray) | Baseline, 24 Weeks and 48 Weeks |
| Wheaton |
| Maryland |
| 20902 |
| United States |
| Lake Success | New York | 11042 | United States |
| Rochester | New York | 14642 | United States |
| Seattle | Washington | 98104 | United States |
| Victoria | British Columbia | V8V 3P9 | Canada |
| St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| London | Ontario | N6A 4V2 | Canada |
| Newmarket | Ontario | L3Y 3R7 | Canada |
| Toronto | Ontario | K1N 5N1 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Montreal | Quebec | H2L 1S6 | Canada |
| Berlin | D-13125 | Germany |
| Frankfurt | D-60590 | Germany |
| Göttingen | D-37075 | Germany |
| Bialystok | 15-337 | Poland |
| Elblag | 82-300 | Poland |
| Kalisz | 62-800 | Poland |
| Krakow | 30-119 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 02-637 | Poland |
| Moscow | 107076 | Russia |
| Moscow | 115522 | Russia |
| Nizhny Novgorod | 603600 | Russia |
| Saint Petersburg | 190068 | Russia |
| Saint Petersburg | 194044 | Russia |
| Yaroslavl | 150003 | Russia |
| Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25. |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077944 | Alefacept |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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