ACTH Gel Therapy in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02030028|
Recruitment Status : Recruiting
First Posted : January 8, 2014
Last Update Posted : September 12, 2017
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: ACTHAR gel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||October 2018|
Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
Drug: ACTHAR gel
Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
Other Name: Adrenocorticotropic hormone
- Changes in Clinical Disease Activity Index [ Time Frame: 12 weeks ]We propose a 20% improvement after 12 weeks of therapy compared to baseline as a positive response.
- Change in the Disease Activity Score [ Time Frame: 12 weeks ]We expect an improvement in the disease activity score along with an improved C-Reactive protein value.
- Changes in acute phase reactants [ Time Frame: 12 weeks ]We expect the erythrocyte sedimentation rate (ESR) and the C-reactive protein value to improve.
- Patient reported changes in fatigue [ Time Frame: 12 weeks ]We expect patient to report using the FACIT-F scoring tool to report improvement in their level of fatigue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030028
|Contact: Laurie Hope, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Laurie Hope, RN 412-647-2638 email@example.com|
|Principal Investigator: Larry W Moreland, MD|
|Principal Investigator:||Larry W Moreland, MD||University of Pittsburgh|