Clinical trial NCT00927927
Conditions: Inflammation Rheumatoid Arthritis
Sponsor: Janssen Research & Development, LLC
Start date: 2009-06-01; Completion date: 2011-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

Detailed description:

Arms: arm 1: Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg arm 2: Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg arm 3: Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg arm 4: Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg arm 5: Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg arm 6: Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg arm 7: Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg arm 8: Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg arm 9: Subjects were injected once with placebo arm 10: Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg arm 11: Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg arm 12: Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg arm 13: Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg arm 14: Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg arm 15: Subjects were injected biweekly four times with placebo
Interventions: intervention 1: NNC0142-0002 intervention 2: NNC0142-0002 intervention 3: NNC0142-0002 intervention 4: NNC0142-0002 intervention 5: NNC0142-0002 intervention 6: NNC0142-0002 intervention 7: NNC0142-0002 intervention 8: NNC0142-0002 intervention 9: placebo intervention 10: NNC0142-0002 intervention 11: NNC0142-0002 intervention 12: NNC0142-0002 intervention 13: NNC0142-0002 intervention 14: NNC0142-0002 intervention 15: placebo
Intervention descriptions: intervention 1: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 2: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 3: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 4: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 5: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 6: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 7: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 8: Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 intervention 9: Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times intervention 10: Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly intervention 11: Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly intervention 12: Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly intervention 13: Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly intervention 14: Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly intervention 15: Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

Protocol documents: