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Mycophenolate After Stem Cell Transplant for Systemic Sclerosis

ConditionSystemic Sclerosis (SSc)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .

We are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.

Disqualifiers

Exclusion criteria are focused on patient safety, namely inability to receive treatment with

Renal insufficiency (eGFR <25 mL/minute/1.73m2) or

Neutropenia (ANC <1.0 x 103/mcL) or

Thrombocytopenia (platelet count <50 000/mcL)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mycophenolate Mofetil 1000 mg twice daily

    Drug

    MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT and continued for 6 months.

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: Mycophenolate mofetil (MMF)Experimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility:

The number of participants enrolled at a single center over 18 months.

Time frame
18 months
2

Efficacy :

-Proportion of patients showing an increase in mRSS of \>7 between timepoints .

Time frame
At day 0,90,180 and 270
3

Safety : AEs/SAEs

The proportion of patients experiencing a serious AE OR an AE greater that grade 2 (see below) OR an AE requiring discontinuation of the study drug in a participant who has received at least one dose of the study intervention

Time frame
Day 90 (treatment start) , Day 180, day 270
4

Efficacy:

-Proportion of patients requiring initiation of immunosuppressive therapy for progressive SSc manifestations as determined by their treating physicians.

Time frame
At day 0,90,180 and 270

Secondary outcomes

1

Feasibility: Consent rate:

Proportion of eligible patients who provide consent .

Time frame
Both prior to AHSCT (clinic visit #1) and at day 90 (clinic visit #3) prior to randomization.
2

Feasibility: Retention rate: Proportion of participants retained

Proportion of participants retained

Time frame
Day 270 (clinic visit #5)
3

Feasibility: Study completion rate:

Proportion of participants who completed proposed clinical outcomes at all pre determined time points

Time frame
Day 270
4

Feasibility: Adherence rate:

Adherence to study drug measured by proportion of prophylaxis doses received measured by pill counting at follow-up visits.

Time frame
Day 180 and Day 270

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: