Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GA00932 | Other Identifier | Hoffmann-La Roche |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLTA3698A | Drug | Subcutaneous repeating dose |
| |
| adalimumab |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR | Day 85 | |
| Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A | Length of study (through Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response ) | Day 85 | |
| ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John C. Davis, Jr., M.D., M.P.H. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25359150 | Derived | Kennedy WP, Simon JA, Offutt C, Horn P, Herman A, Townsend MJ, Tang MT, Grogan JL, Hsieh F, Davis JC. Efficacy and safety of pateclizumab (anti-lymphotoxin-alpha) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study). Arthritis Res Ther. 2014 Oct 30;16(5):467. doi: 10.1186/s13075-014-0467-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Subcutaneous repeating dose |
|
| leflunomide | Drug | Stable dose if not on methotrexate |
|
| methotrexate | Drug | Stable dose if not on leflunomide |
|
| placebo | Drug | Subcutaneous repeating dose |
|
| Day 85 |
| ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response) | Day 85 |
| Tender joint count | Day 85 |
| Swollen joint count | Day 85 |
| Investigator Global Assessment of Disease Activity | Day 85 |
| Patient Global Assessment of Pain and Disease Activity | Day 85 |
| Health Assessment Questionnaire Disability Index | Day 85 |
| Patient's Global Health or Short Form Health Survey (SF-36) | Day 85 |
| European League Against Rheumatism response rate | Day 85 |
| Serum C-reactive protein levels | Day 85 |
| Erythrocyte sedimentation rate | Day 85 |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Peoria | Arizona | 85381 | United States |
| Los Angeles | California | 90033 | United States |
| Upland | California | 91786 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Lexington | Kentucky | 40515 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Flowood | Mississippi | 39232 | United States |
| Reno | Nevada | 89502 | United States |
| Charleston | South Carolina | 29406 | United States |
| San Antonio | Texas | 78217 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Clarksburg | West Virginia | 26301 | United States |
| Sofia | 1233 | Bulgaria |
| Sofia | 1407 | Bulgaria |
| Sofia | 1505 | Bulgaria |
| Santiago | 00000 | Chile |
| Santiago | 7501126 | Chile |
| Santiago | 7510186 | Chile |
| Bad Nauheim | 61231 | Germany |
| Berlin | 14059 | Germany |
| Cologne | 50924 | Germany |
| Erfurt | 99096 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Herne | 44649 | Germany |
| Kiel | 24105 | Germany |
| Zerbst | 39261 | Germany |
| Békéscsaba | 5600 | Hungary |
| Budapest | 1027 | Hungary |
| Budapest | 1036 | Hungary |
| Debrecen | 4032 | Hungary |
| Veszprém | H-8200 | Hungary |
| Culiacán | 80000 | Mexico |
| Guadalajara | 44340 | Mexico |
| Guadalajara | 44600 | Mexico |
| Guadalajara | 44690 | Mexico |
| León | 37320 | Mexico |
| Mexicali | 21100 | Mexico |
| Mexico City | 06700 | Mexico |
| Mérida | 97000 | Mexico |
| México | 44620 | Mexico |
| Monterrey, NL | 64000 | Mexico |
| Lima | 41 | Peru |
| Lima | Lima 1 | Peru |
| Lima | Lima 25 | Peru |
| Lima | Lima 27 | Peru |
| Lima | Lima 34 | Peru |
| Lima | Lima 41 | Peru |
| San Isidro | L27 Lima | Peru |
| San Isidro | Lima 27 | Peru |
| Bialystok | 15-099 | Poland |
| Bialystok | 15-461 | Poland |
| Elblag | 82-300 | Poland |
| Kościan | 64-000 | Poland |
| Krakow | 30-510 | Poland |
| Lublin | 20-607 | Poland |
| Warsaw | 02-653 | Poland |
| Baia Mare | 430031 | Romania |
| Bucharest | 010584 | Romania |
| Bucharest | 011172 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Galati | 800578 | Romania |
| Torrelavega | Cantabria | 39300 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Seville | Sevilla | 41071 | Spain |
| S. Cristobal de La Laguna | Tenerife | 38320 | Spain |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C576689 | pateclizumab |
| D000068879 | Adalimumab |
| D000077339 | Leflunomide |
| 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 |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided