Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
Phase 2
Terminated
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: KB003Other: Placebo Comparator
- Registration Number
- NCT00995449
- Lead Sponsor
- Humanigen, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- At least 6 swollen and at least 6 tender joints
- C-reactive Protein (CRP) > Upper Limit Normal (ULN)
- Prior inadequate response from biologic therapy
- Stable regimens of concomitant RA therapies
Exclusion Criteria
- Unstable medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KB003 70 mg KB003 - Placebo Placebo Comparator - KB003 200 mg KB003 - KB003 600 mg KB003 -
- Primary Outcome Measures
Name Time Method This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. Weeks 14 & 30 KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)
- Secondary Outcome Measures
Name Time Method