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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|