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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00291928 | HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | PHASE2 | COMPLETED | 201 | — | — | Feb 1, 2005 | Sep 1, 2007 | Nov 12, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| Dose ranging | PLACEBO_COMPARATOR | A double-blind, placebo controlled, dose escalation part randomized within each of 3 sequential cohorts (Part A), |
| Parallel Arm RCT | PLACEBO_COMPARATOR | a parallel group part with randomization into one of 4 treatment arms (Part B). |
| Name | Type | Description |
|---|---|---|
| Part A | DRUG | Part A Cohort 1: HuMax-CD20 300 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 2: HuMax-CD20 700 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 3: HuMax-CD20 1000 mg at Days 0 and 14 or Placebo at Days 0 and 14 |
| Part B | DRUG | Part B Group 1: HuMax-CD20 300 mg at Days 0 and 14 Group 2: HuMax-CD20 700 mg at Days 0 and 14 Group 3: HuMax-CD20 1000 mg at Days 0 and 14 Group 4: Placebo at Days 0 and 14 |
Inclusion Criteria: * Age ≥ 18 years * Active rheumatoid arthritis according to the American College of Rheumatology of at least six months duration with six or more swollen and six or more tender joints (of 28 joints) and Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/h and/or C-Reactive Protein (CR...