Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT02981082|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Pulmonary; Hypertension||Drug: Dimethyl Fumarate (DMF) Drug: Placebo Oral Tablet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Dimethyl Fumarate (DMF)
Twice daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days followed by the maintenance dose of Dimethyl Fumarate (DMF) 240mg twice a day. Subjects will be dosed for 24 weeks
Drug: Dimethyl Fumarate (DMF)
Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.
Other Name: Tecfidera
Placebo Comparator: Placebo
Twice daily oral doses of placebo for 12 weeks
Drug: Placebo Oral Tablet
Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)
- 6 minute walk distance (6MWD). [ Time Frame: Baseline to Week 24 ]The primary outcome of clinical efficacy in this study will be improvement in 6‐minute walk distance (6MWD).
- Clinical Worsening [ Time Frame: Baseline to Week 24 ]The change in time to clinical worsening in DMF compared to placebo treated patients.
- Borg Dyspnea Index (BDI) [ Time Frame: Baseline to Week 24 ]The change in Borg Dyspnea Index (BDI) at 24 weeks from baseline in DMF compared to placebo treated patients
- Serum markers of oxidative stress [ Time Frame: Baseline to Week 24 ]The change from baseline of serum markers of oxidative stress at 24 weeks, comparing DMF to placebo treated patients.
- Proteomic biomarkers [ Time Frame: Baseline to Week 24 ]The change from baseline in proteomic biomarkers, including BNP, at 24 weeks, comparing DMF to placebo treated patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981082
|Contact: Robert A Lafyatis, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Maureen M Laffoon, BS 412-648-7871 email@example.com|
|Contact: Dana Ivanco, EMT 412-648-7040 firstname.lastname@example.org|
|Principal Investigator: Robert A Lafyatis, MD|
|Principal Investigator:||Robert A Lafyatis, MD||University of Pittsburgh|