Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Funding withdrawn
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ozanimod | Patients with UC starting ozanimod therapy as part of their clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Patients with established diagnosis of UC starting ozanimod therapy as part of their clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | The primary endpoint measure is clinical response defined as a decrease of at least 50% in PRO2 at week 10 (end of induction) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Clinical response defined as a decrease of at least 50% in PRO2 at week 22 | 22 weeks |
| Clinical remission | Symptomatic/PRO2 remission defined as stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0 at weeks 10 and 22. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurie Grossberg, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607776 | ozanimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 weeks |
| Fecal calprotectin | Change from baseline in level of fecal calprotectin at weeks 2, 10, and 22 | 2, 10, 22 weeks |
| CRP | Change from baseline in level of CRP at weeks 2, 10, 22 | 2, 10, 22 weeks |
| Corticosteroid free remission | Corticosteroid free remission at week 22 | 22 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |