Phase 2
Completed N=208
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
Source: ClinicalTrials.gov NCT00903383 ↗Enrolled (actual)
208
Serious AEs
1.0%
Results posted
Dec 2011
Primary outcomePrimary: ACR20 Response at Week 12 — 24; 22; 30; 24 Participants
Summary
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR20 Response at Week 12 |
24; 22; 30; 24 | — |
| SECONDARY ACR50 Response at Week 12 |
6; 5; 11; 12 | — |
| SECONDARY ACR70 Response at Week 12 |
2; 4; 5; 3 | — |
| SECONDARY Hybrid ACR Response at Week 12 |
26.595; 27.422; 37.356; 35.290 | — |
| SECONDARY Change From Baseline in C-reactive Protein (mg/L) at Week 12 |
-0.026; 5.342; -5.316; -7.983 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12 |
-2.5; -3.3; -9.7; -7.6 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged 18-75 years old
- Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
- Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level > upper limit of normal
- Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
- Ability to provide written informed consent
Exclusion Criteria
- RA diagnosis prior to 16 years of age (Juvenile RA)
- Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to >1 biologic DMARD
- Use of DMARDs other than MTX within 12 weeks prior to Day 1
- Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
- Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
- Major surgical procedure within 8 weeks prior to Day 1
- Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
- History of cancer within 5 years prior to Day 1
- Presence of hepatic or biliary disease
- History of tuberculosis
- History of human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT00903383). 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.