Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01370902 | Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 92 | — | — | May 1, 2011 | Mar 1, 2014 | Dec 23, 2014 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Single-dose (SD) trial part (i.v.) | EXPERIMENTAL | - |
| Single-dose (SD) trial part (s.c.) | EXPERIMENTAL | - |
| Multiple-dose (MD) trial part (s.c.) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC 0141-0000-0100 | DRUG | Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part |
| placebo | DRUG | Single dose administered subcutaneously (under the skin) as a comparator at all dose levels |
Inclusion Criteria: * A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation * Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calcul...