← Back to Search

Anti-metabolites

Prednisone/Prednisolone Dosing for Cardiac Sarcoidosis (CHASM-CS-RCT Trial)

Phase 3

Recruiting

Led By David H Birnie, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease (defined as Mobitz II AV block or third degree AV block), significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias), non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction (LVEF < 50%), right ventricular dysfunction (RVEF < 40%)

CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy

Must not have

Currently taking Methotrexate or Prednisone for another health condition

Patient is unable or unwilling to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 30 Other Conditions

Summary

This trial is comparing the effectiveness of two different doses of Prednisone (or Prednisolone), one standard and one low, in patients with cardiac sarcoidosis who have not yet been treated. The Investigators hypothesize that the low dose will be just as effective as the standard dose, but with better quality of life and less toxicity.

Who is the study for?

This trial is for patients with acute active cardiac sarcoidosis, confirmed by PET scans and biopsies, who haven't been treated yet. They should have specific heart issues like arrhythmias or reduced heart function but can't be pregnant, breastfeeding, or on Methotrexate/Prednisone for other conditions.

What is being tested?

The study compares a low dose combo of Prednisone (or Prednisolone) with Methotrexate to a standard dose of Prednisone alone in treating cardiac sarcoidosis. The goal is to see if the combo works as well while improving life quality and causing less toxicity.

What are the potential side effects?

Possible side effects include increased risk of infections, mood swings, high blood sugar levels from Prednisone; and liver damage, lung issues, or mouth sores from Methotrexate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have heart issues due to sarcoidosis, like irregular heartbeats or weak heart muscles.

Select...

My CT scan shows signs of sarcoidosis or swollen lymph nodes in my chest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on Methotrexate or Prednisone for a health condition.

Select...

I cannot or do not want to give permission for treatment.

Select...

I cannot take Methotrexate or Prednisone due to side effects or health reasons.

Select...

I am a woman of childbearing age and I refuse to use effective birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summed perfusion rest score (SPRS) on FDG-PET scan

Secondary study objectives

BMI

Blood pressure

CMR Endpoints

+16 more

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987

11%

Rheumatoid arthritis

11%

Rhinitis

Asthenia

Bronchitis

Nasopharyngitis

Alanine aminotransferase increased

Arthralgia

Headache

Neutropenia

Diarrhoea

Back pain

Hepatocellular injury

Transaminases increased

Insomnia

Abdominal pain

Urinary tract infection

Ear infection

Injection site erythema

Pruritus

Nausea

Hypertension

Gastric volvulus

Angioedema

Gastric ulcer

Intestinal ischaemia

Pulmonary embolism

Deep vein thrombosis

Hypertensive crisis

Iron deficiency anaemia

Cataract

Cervical dysplasia

Disseminated tuberculosis

Septic shock

Meningitis tuberculous

Fall

100%

80%

60%

40%

20%

Study treatment Arm

TCZ COMBO - All Participants

TCZ MONO - All Participants

TCZ - All Participants

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MethotrexateExperimental Treatment2 Interventions

\[Dose everywhere except Japan\] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid OD (exact dose and directions at physicians discretion) for 6 months. \[Dose in Japan\] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.

Group II: Prednisone (or Prednisolone)Active Control1 Intervention

\[Dose everywhere except Japan\] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg) \[Dose in Japan\] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

FDA approved

Methotrexate

FDA approved

0 / 6Eligibility criteria met