Phase 2
Completed N=98
Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01023256 ↗Enrolled (actual)
98
Serious AEs
1.8%
Results posted
May 2014
Primary outcomePrimary: Percentages of Patients With Treatment-emergent or Serious Adverse Events — 54.2; 63.6; 65.2; 60.9 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Patients With Treatment-emergent or Serious Adverse Events |
54.2; 63.6; 65.2; 60.9; 44.4; 4.2 | — |
| SECONDARY Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks |
-0.2; -1.1; -0.6; 0.2 | 0.095 |
| SECONDARY Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks |
-0.3; -1.0; -0.6; -0.1 | 0.421 |
| SECONDARY Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4 |
25.0; 68.2; 30.4; 7.4 | 0.243 |
| SECONDARY Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8 |
-1.7; -3.5; -3.3; 0.1; -1.9; -4.1 | — |
| SECONDARY Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 |
-8.6; -17.4; -11.4; -3.3; -4.1; -13.4 | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis (RA) per revised 1987 ACR criteria
- Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
- CRP > 5.0 mg/L (RF and anti-CCP seronegative); CRP >2 mg/l (RF and/or anti-CCP seropositive)
- DAS28 ≤ 5.1
- Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
- Negative PPD tuberculin skin test
Exclusion Criteria
- Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
- Any history of ongoing, significant or recurring infections
- Any active inflammatory diseases other than RA
- Treatment with a systemic investigational drug within 6 months prior to screening
- Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
- Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
- Hepatic or renal insufficiency
Data sourced from ClinicalTrials.gov (NCT01023256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.