Trial · NCT01829295
Methotrexate and Mycophenolate Mofetil for UVEITIS
NCT01829295, Phase 3, Completed, University of California, San Francisco; results first posted 2019-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methotrexate and Mycophenolate Mofetil for UVEITIS. Trials, record NCT01829295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01829295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methotrexate and Mycophenolate Mofetil for UVEITIS
- NCT number
- NCT01829295
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Uveitis
- Interventions
- Mycophenolate mofetil, Methotrexate, Prednisone
- First posted
- 2013-04-11
- Last updated
- 2024-04-02
- Results first posted
- 2019-04-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) | 6 Months | Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate. |
| Secondary | Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) | 12 Months | Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months. |
| Secondary | Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) | 6 Months | Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) | 6 Months | All randomized patient with a 6-month visit, or who were declared early treatment failures, are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) | 12 Months | Patients who were a treatment success at 6 months and continued in follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) | 6 Months | Patients who switched to the other medication following treatment failure at 6 months (or earlier). Patients were analyzed by the medication that they received in this second phase (Phase II, 0-6 Months). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) | Methotrexate | 64 | Participants | ||
| Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) | Mycophenolate Mofetil | 56 | Participants | ||
| Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) | Methotrexate | 48 | Participants | ||
| Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) | Mycophenolate Mofetil | 40 | Participants | ||
| Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) | Switched Over to Methotrexate | 20 | Participants | ||
| Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) | Switched Over to Mycophenolate Mofetil | 7 | Participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 0-6 Months | STARTED | Methotrexate Only | 107 | |
| 0-6 Months | STARTED | Mycophenolate Mofetil Only | 109 | |
| 0-6 Months | STARTED | Methotrexate, Then Mycophenolate Mofetil | 0 | |
| 0-6 Months | STARTED | Mycophenolate Mofetil, Then Methotrexate | 0 | |
| 0-6 Months | COMPLETED | Methotrexate Only | 96 | |
| 0-6 Months | COMPLETED | Mycophenolate Mofetil Only | 98 | |
| 0-6 Months | COMPLETED | Methotrexate, Then Mycophenolate Mofetil | 0 | |
| 0-6 Months | COMPLETED | Mycophenolate Mofetil, Then Methotrexate | 0 | |
| 0-6 Months | NOT COMPLETED | Methotrexate Only | 11 | |
| 0-6 Months | NOT COMPLETED | Mycophenolate Mofetil Only | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | Methotrexate | 5 | 107 | |
| other | Cataract | Eye disorders | Mycophenolate Mofetil | 2 | 109 | |
| other | Suspected/confirmed glaucoma diagnosis | Eye disorders | Methotrexate | 2 | 107 | |
| other | Suspected/confirmed glaucoma diagnosis | Eye disorders | Mycophenolate Mofetil | 2 | 109 | |
| other | Hypotony | Eye disorders | Methotrexate | 0 | 107 | |
| other | Hypotony | Eye disorders | Mycophenolate Mofetil | 1 | 109 | |
| other | Ocular hypertension | Eye disorders | Methotrexate | 10 | 107 | |
| other | Ocular hypertension | Eye disorders | Mycophenolate Mofetil | 13 | 109 | |
| other | Peripheral and/or central vitreous hemorrhage | Eye disorders | Methotrexate | 3 | 107 | |
| other | Peripheral and/or central vitreous hemorrhage | Eye disorders | Mycophenolate Mofetil | 3 | 109 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate | 1 | 107 |
| Total, all-cause mortality | Mycophenolate Mofetil | 0 | 109 |
| Total, other adverse events | Methotrexate | 99 | 107 |
| Total, other adverse events | Mycophenolate Mofetil | 100 | 109 |
| Total, serious adverse events | Methotrexate | 7 | 107 |
| Total, serious adverse events | Mycophenolate Mofetil | 7 | 109 |
Source ClinicalTrials.gov
Papers27
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY021125 | First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial | ACHARYA, NISHA | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL EYE INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methotrexate vs Mycophenolate Mofetil: Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months) | Trial comparisons |
| Switched Over to Methotrexate vs Switched Over to Mycophenolate Mofetil: Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months) | Trial comparisons |
| Methotrexate vs Mycophenolate Mofetil: Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) | Trial comparisons |
| Methotrexate vs Mycophenolate Mofetil: deaths from any cause | Trial comparisons |
| Methotrexate vs Mycophenolate Mofetil: serious adverse events | Trial comparisons |
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/NCT01829295
GET https://conductscience.org/api/trials/v1/NCT01829295/flow?page=2