NCT02258217

Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

Detailed description

We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Acthar	Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-06-24
• Completion: 2016-12-01
• First posted: 2014-10-07
• Last updated: 2020-09-01
• Results posted: 2020-09-01

Locations

1 site across 1 country: United States