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The investigators hypothesize that Mycobacterium avium paratuberculosis positive Relapsing Remitting MS subjects will have a greater response to Interferon beta-1a therapy plus RHB-104 than from Interferon beta-1a alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHB-104 | Experimental | 5 RHB-104 capsules administered orally BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHB-104 | Drug | 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Unique Active lesions | Baseline through Wk 24 |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined Unique Active lesions | Week 24 to Week 48 | |
| Change in cytokine panel | Baseline to Week 24 | |
| Change in cytokine panel |
Inclusion Criteria:
Exclusion Criteria:
If positive history of previously treated Hepatitis C, but HCV PCR is undetectable off medications for at least 6 months prior to screening, and treating hepatologist or infectious disease specialist believes the subject is cured - subject may be enrolled
History of atypical mycobacterial infections (other than MAP). History of active tuberculosis (TB) requiring treatment in the past 3 years. Tuberculosis infection as determined by a positive diagnostic TB test result (defined as a positive or indeterminate (after two independent tests) quantiFERON TB Test Gold test).
Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist.
Any evidence of any other significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, thyroid, neurological or psychiatric disease that might interfere with the subject's ability to safely enter and or complete the study requirements.
History of malignancy within the past five years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
Males who do not use barrier contraceptive methods (i.e. condom) with spermicidal foam/gel/cream/suppository or have not had a vasectomy.
Females who:
Refusal to sign the study informed consent form.
Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.
History of drug or alcohol abuse within the past 3 years.
Participation in any experimental drug protocol within 12 weeks of date of screening.
Cardiac pacemaker or any other type of metal implant or any other contraindication for MRI (including known allergy to gadolinium).
QTc greater than 440ms, bundle branch block, or major ST or T wave abnormalities that make the assessment of the QT impossible.
History of unstable cardiac syndromes including unstable angina, coronary artery bypass graft, myocardial infarction or coronary stenting within 2 months of screening; NYHA Class 3-4 CHF; history of ventricular tachycardia, ventricular fibrillation, personal or family history of sudden death, Long QT Syndrome, or Torsade de Pointes; HR<50BPM; having taken any Class 1 or Class 3 antiarrhythmic medications or medicines known to prolong the QT interval or be associated with Torsade de Pointes.
Treatment with medical cannabis in the 4 weeks prior to screening.
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| Name | Affiliation | Role |
|---|---|---|
| Ira N Kalfus, MD | RedHill Biopharma | Study Director |
| Radi Shahien, MD | Ziv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RedHill MS Clinical Trial Site 002 | Tel Aviv | Israel | ||||
| RedHill MS Clinical Trials Site 001 |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| Week 24 to Week 48 |
| MAP status as established by polymerase chain reaction (PCR) | Baseline to Week 24 |
| MAP status as established by polymerase chain reaction (PCR) | Week 24 to Week 48 |
| Relapses | Baseline to Week 24 |
| Relapses | Week 24 to Week 48 |
| Expanded Disability Status Scale (EDSS) | Baseline to Week 24 |
| Expanded Disability Status Scale (EDSS) | Week 24 to Week 48 |
| T2-hyperintense lesions | Baseline to Week 24 |
| T2-hyperintense lesions | Week 24 to Week 48 |
| T1 post-gadolinium lesions | Baseline to Week 24 |
| T1 post-gadolinium lesions | Week 24 to Week 48 |
| Burden of Disease | Baseline to Week 24 |
| Burden of Disease | Week 24 to Week 48 |
| Number of participants with adverse events | Baseline through Week 24 |
| Zefat (Safed) |
| Israel |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |