Trial Details
RecruitingBasic Information
| Clinical ID | c2397 |
|---|---|
| Identifier | ACTRN12621000661875 |
| Trial Title | Antibody response to COVID-19 vaccination in immunosuppressed patients with autoimmune disease |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Rheumatoid arthritis;Psoriatic arthritis;Ankylosing spondylitis;Crohn's Disease;Ulcerative Colitis;COVID-19;Inflammatory bowel disease; Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis Crohn's Disease Ulcerative Colitis COVID-19 Inflammatory bowel disease;Inflammatory and Immune System - Autoimmune diseases;Oral and Gastrointestinal - Crohn's disease;Oral and Gastrointestinal - Inflammatory bowel disease;Musculoskeletal - Other muscular and skeletal disorders;Infection - Other infectious diseases;Inflammatory and Immune System - Other inflammatory or immune system disorders;Inflammatory and Immune System - Rheumatoid arthritis |
| Interventions | Patients who are planning to have the COVID-19 vaccination will be followed. Patients having the AstraZenca vaccine will have the vaccination at weeks 0 and 12, while the patients receiving the Pfizer vaccination will receive it on weeks 0 and 4. The vaccinations will be provided by their general practitioner. Records from their GP or from My Health Record will be obtained to confirm vaccine administration. The only intervention is some patients will be randomly assigned to withhold their immunosuppressive medications for 1 week after the first vaccine dose only. There are no adherence measures implemented to confirm if patients a compliant to the instructions of continuing or withholding their medication. A member of the research team will instruct the patient which arm they have been assigned to. |
Participant Information
| Sponsor | Dr Ai Tran |
|---|---|
| City | - |
| Country/Region | Australia |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE4 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |