Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
|ClinicalTrials.gov Identifier: NCT01966718|
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Repository corticotropin injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Repository corticotropin injection
Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Drug: Repository corticotropin injection
An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances
Other Name: H. P. Acthar Gel
- Change From Baseline in the Ritchey-Camp Articular Index [ Time Frame: From baseline to week 16 ]Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.
- Change From Baseline in the 20-item Health Assessment Questionnaire Score [ Time Frame: From baseline to week 16 ]Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.
- Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) [ Time Frame: From baseline to week 16 ]ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased
- Change From Baseline in the C-Reactive Protein (CRP) Level [ Time Frame: From baseline to week 16 ]CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966718
|United States, Maryland|
|Arthritis Treatment Center|
|Frederick, Maryland, United States, 21702|
|Principal Investigator:||Nathan Wei, MD||Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA|