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NCT00903383 · ClinicalTrials.gov registry record · Phase 2
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
A Phase 2 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
NCT00903383: Completed Phase 2 study, sponsored by Lexicon Pharmaceuticals.
NCT00903383 is a Phase 2 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00903383, a Phase 2 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
Study 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.
Primary Outcome
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-
Interventions
- DRUG Placebo
- DRUG LX3305 low dose
- DRUG LX3305 mid dose
- DRUG LX3305 high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00903383 record still lists
NCT00903383 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00903383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00903383 about?
NCT00903383 is a clinical study titled "Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate". 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.
What is the current status of trial NCT00903383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2009-07.
What interventions are being tested in trial NCT00903383?
The interventions under investigation include: Placebo (DRUG), LX3305 low dose (DRUG), LX3305 mid dose (DRUG), LX3305 high dose (DRUG).
Who is sponsoring clinical trial NCT00903383?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00903383's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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