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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01181050 | Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA) | PHASE2 | COMPLETED | 63 | — | — | Aug 1, 2010 | Apr 1, 2012 | Oct 3, 2016 | 3 | Germany, Russia +1 |
| NCT00927927 | First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 65 | — | — | Jun 1, 2009 | Dec 1, 2011 | Oct 3, 2016 | 1 | Germany |
DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
| Arm | Type | Description |
|---|---|---|
| 4.0 mg/kg | EXPERIMENTAL | Subjects received a single dose of 4 mg/kg NNC0142-0002 |
| Placebo | PLACEBO_COMPARATOR | Subjects received a single dose of placebo |
| SD 0.0002 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg |
| SD 0.0012 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg |
| SD 0.007 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg |
| SD 0.035 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg |
| SD 0.175 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg |
| SD 0.7 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg |
| SD 2.5 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg |
| SD 7.5 mg/kg | EXPERIMENTAL | Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg |
| SD Placebo | EXPERIMENTAL | Subjects were injected once with placebo |
| MD 0.02 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg |
| MD 0.3 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg |
| MD 1.0 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg |
| MD 1.6 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg |
| MD 4.0 mg/kg | EXPERIMENTAL | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg |
| MD Placebo | EXPERIMENTAL | Subjects were injected biweekly four times with placebo |
| Name | Type | Description |
|---|---|---|
| NNC0142-0002 | DRUG | A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
| placebo | DRUG | A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
Inclusion Criteria: * A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product * Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swo...