At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 96 enrolled
Drug / intervention
MOR103 +2 moredrug
Likely dose
MOR103 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis
In Brief
A Phase 2 clinical trial evaluating MOR103 for Rheumatoid Arthritis. Completed, enrolled 96 participants across 5 sites in 5 countries.
Detailed Summary
GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Germany, Netherlands, Poland, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionJun 2012
TodayJul 2026
First PostedDec 2, 2009
Enrollment StartDec 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.6 years ago
Interventions
MOR103drug
MOR103 0.3 mg/kg or placebo iv x 4 doses
MOR103drug
MOR103 1.0 mg/kg or placebo iv x 4 doses
MOR103drug
MOR103 1.5 mg/kg or placebo iv x 4 doses