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NCT04057118 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
A Phase 2 study, sponsored by Oscotec.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT04057118: Completed Phase 2 study, sponsored by Oscotec.
NCT04057118 is a Phase 2 study that has completed, run by Oscotec. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057118, a Phase 2 study, has completed, sponsored by Oscotec.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.
Primary Outcome
Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural
Interventions
- DRUG Placebo
- DRUG SKI-O-703
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2020-10-13 |
| Phase | Phase 2 |
What the finished NCT04057118 record still lists
NCT04057118 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04057118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04057118 about?
NCT04057118 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.". This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of...
What is the current status of trial NCT04057118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2019-03-20. Estimated completion is 2020-10-13.
What interventions are being tested in trial NCT04057118?
The interventions under investigation include: Placebo (DRUG), SKI-O-703 (DRUG).
Who is sponsoring clinical trial NCT04057118?
This trial is sponsored by Oscotec, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04057118's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 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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