Trial · NCT03163966
A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis
NCT03163966, Phase 2, Completed, Rottapharm Biotech
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis. Trials, record NCT03163966. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03163966
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis
- NCT number
- NCT03163966
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 248 participants, actual
- Lead sponsor
- Rottapharm Biotech
- Conditions
- Rheumatoid Arthritis, DMARD-naive and Early Disease Patients
- Interventions
- CR6086, Methotrexate, Placebo
- First posted
- 2017-05-23
- Last updated
- 2021-10-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | American College of Rheumatology 20% improvement (ACR20) responder rate | 12 weeks | |
| Secondary | ACR50 responder rate | 12 weeks | |
| Secondary | ACR70 responder rate | 12 weeks | |
| Secondary | Disease Activity Score on 28-joint count (DAS28) | 12 weeks | |
| Secondary | Clinical Disease Activity Index (CDAI) | 12 weeks | |
| Secondary | Simplified Disease Activity Index (SDAI) | 12 weeks | |
| Secondary | ACR/EULAR remission criteria | 12 weeks | |
| Secondary | Adverse Events | 12 weeks | number of patients with Adverse Events |
| Secondary | Routine Laboratory determinations | 12 weeks | |
| Secondary | Pharmacokinetics (PK) of Methotrexate and CR6086 in combination | 12 weeks | Main PK endpoint: AUCinf (ng.h/mL). Area under the plasma concentration vs time curve extrapolated to infinity |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03163966
GET https://conductscience.org/api/trials/v1/NCT03163966/registered