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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523579-47-00 | EU Trial (CTIS) Number |
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The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart Group I | Experimental | Participants will recieve Afimkibart as subcutaneous (SC) injection. |
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| Afimkibart Group II | Experimental | Participants will receive Afimkibart as SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Participants will receive Afimkibart as per the schedule mentioned in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | From Baseline up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) | Up to 6 years | |
| Change from baseline in Individual Components of ACR | Baseline, Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DM Clinical Research | Recruiting | Tomball | Texas | 77375 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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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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| Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP) | Baseline, Up to 6 years |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score | Up to 6 years |
| Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score | Up to 6 years |
| Percentage of Participants Achieving LDA Based Clinical Disease Activity Index (CDAI) Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-CRP Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28-ESR Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on CDAI Score | Up to 6 years |
| Percentage of Participants Achieving Clinical Remission (CR) Based on SDAI Score | Up to 6 years |
| Serum Concentration of Afimkibart | Up to 6 years |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart at Baseline and with ADAs to Afimkibart During the Study | Baseline, Up to 6 years |
| Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart | Up to 6 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |