Trial · NCT04927390
Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
NCT04927390, Phase 2, Unknown, University College, London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot). Trials, record NCT04927390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04927390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
- NCT number
- NCT04927390
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- University College, London
- Conditions
- Systemic Sclerosis, Limited Cutaneous Systemic Sclerosis
- Interventions
- Mycophenolate Mofetil 500mg
- First posted
- 2021-06-16
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2019-004139-21
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The total number of lcSSc patients screened during the 12 month recruitment period, measured from information provided on the site Screening Logs | From first site activation up to a period of 12 months | The total number of lcSSc patients screened will be captured on detailed screening logs |
| Primary | The proportion of participants who provide consent during the 12 month recruitment period, measured from information provided on the site Screening Logs | From first site activation up to a period of 12 months | Participant informed consent will be captured in detailed screening logs |
| Primary | The proportion of participants who meet the eligibility criteria during the 12 month recruitment period, measured from information provided on the site Screening Logs | From first site activation up to a period of 12 months | Information on participants who meet the eligibility criteria will be captured on detailed screening logs |
| Primary | Adherence to trial treatment by participants randomised to the MMF arm as assessed by the Participant Dosing Diaries. | From Baseline, up until a minimum of 48 weeks or a maximum of 96 weeks | Participant self-reported adherence using participant dosing diaries to be completed daily. Diaries will be provided to all participants randomised to MMF to record their daily trial medication intake, in addition to any dose modifications and dose interruptions for the duration of their time in the study. |
| Primary | Drug adherence rate from participants randomised to the MMF arm, measured by Pharmacy Accountability Logs | From first participant dispensing, through study completion up to 36 months | Pharmacy dispensing accountability logs will record the number of pills dispensed at each visit and the number of pills returned by the participant.(i.e. pill count) The number of pills taken is calculated by subtracting the count of the number of pills remaining from the total number of pills dispensed. The drug adherence rate is then calculated by dividing the number of pills taken by number of days elapsed since the last dispense. |
| Primary | Adherence to the study protocol by participating sites as assessed by the number of protocol deviations reported using the Protocol Deviation Reports | From Screening, through study completion up to 36 months | Sites to report deviations and sponsor protocol compliance reviews during central, remote and on-site monitoring to be reported in Protocol Deviation Reports. |
| Primary | The proportion of participants intolerant to MMF who discontinue trial treatment from Baseline for a minimum of 48 weeks or a maximum of 96 weeks as assessed by the Participant withdrawal Logs | From Baseline, up until a minimum of 48 weeks or a maximum of 96 weeks | The number of participants who withdraw from trial treatment ONLY will be recorded using detailed Participant Withdrawal Logs |
| Primary | The total number of participants randomised to MMF who reach the target dose of 2g a day, measured by medication intake information captured in the Participant Dosing Diaries | From Baseline through to study completion for a minimum of 48 weeks or a maximum of 96 weeks | Self-reported: Participant Dosing Diaries will be provided to all participants randomised to MMF to record dose escalation information and daily intake of the IMP . |
| Primary | The total number of participants randomised to MMF and Control who reach a clinical worsening of disease progression, measured by the modified Rodnan Skin Score (mRSS) from Baseline, every 6 months until Final trial visit. | From Baseline, every 6 months, through study completion up until a minimum of 48 weeks or a maximum of 96 weeks | Validated physical examination method for estimating skin induration. It is scored on a 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 and is used to categorise severity of SSc. Minimally clinically significant difference in mRSS is 3-5 points. The measurement of time to clinically important disease progression will demonstrate a clinically important advantage of active treatment compared with no immunosuppression if a beneficial effect is found. |
| Primary | The number of participant loss to follow- up as assessed by the Participant Withdrawal Logs | From Baseline, through study completion up until a minimum of 48 weeks or a maximum of 96 weeks | The number of participant loss to follow -up in each group (MMF or control) will be recorded using detailed Participant Withdrawal Logs |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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/NCT04927390
GET https://conductscience.org/api/trials/v1/NCT04927390/registered