Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000225-12 | EudraCT Number | ||
| CNTO148DML1001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Golimumab | Experimental | Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area. |
|
| Group 2: Placebo | Placebo Comparator | Participants will receive a SC matching placebo to golimumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 26 | |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 52 | |
| Percentage of Participants With Treatment-Emergent Infections | Up to Week 26 | |
| Percentage of Participants With Treatment-Emergent Infections | Up to Week 52 | |
| Percentage of Participants With Study Treatment Injection Site Reactions | Up to Week 26 | |
| Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78 | Week 52 to Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Golimumab | Through Week 52 | |
| Incidence of Antibodies to Golimumab | Through Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology | Aurora | Colorado | 80045 | United States | ||
Not provided
| Label | URL |
|---|---|
| Link to results on EudraCT registry. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo to golimumab. |
|
| Children's Hospital of Philadelphia |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Oulu University Hosp. Oulu | Oulu | FI-90014 | Finland |
| Tampere University Hospital | Tampere | FI-33521 | Finland |
| Turku University Hospital | Turku | 20520 | Finland |
| Linkoping University Hospital | Linköping | SE 58185 | Sweden |
| Lund University Hospital/Skåne | Lund/Malmo | 205 02 | Sweden |
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided