Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01369745 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
A Phase 2 study, sponsored by Zalicus.
- Completed
- Registry status
- Phase 2
- Development phase
- 294
- Enrollment target
NCT01369745: Completed Phase 2 study, sponsored by Zalicus.
NCT01369745 is a Phase 2 study that has completed, run by Zalicus. The registered enrollment target is 294 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (121% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369745, a Phase 2 study, has completed, sponsored by Zalicus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 294 participants
- Enrollment target
Study Summary
Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.
Primary Outcome
The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a
Interventions
- DRUG Prednisone
- DRUG Prednisolone
- OTHER placebo
- DRUG dipyridamole
- DRUG Z102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT01369745 record still lists
NCT01369745 is an interventional study that assigns participants to a tested intervention. The registered 294 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 (121% higher).
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT01369745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369745 about?
NCT01369745 is a clinical study titled "A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis". Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.
What is the current status of trial NCT01369745?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 294 participants. The study started on 2011-06. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01369745?
The interventions under investigation include: Prednisone (DRUG), Prednisolone (DRUG), placebo (OTHER), dipyridamole (DRUG), Z102 (DRUG).
Who is sponsoring clinical trial NCT01369745?
This trial is sponsored by Zalicus, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369745's enrollment target sits among peer trials
294 190th of 2000 higher than 1,810 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05775159 · 294 participants · Phase 2
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
- NCT06262113 · 294 participants · NA
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
- NCT06338865 · 294 participants · NA
Short Title: Standard vs. Lower Pressure Pneumoperitoneum
- NCT06395467 · 294 participants · NA
Integrated Treatment for Enhancing Growth in Recovery During Adolescence
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia