Trial Outcomes & Findings for Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies. (NCT NCT01966718)

NCT ID: NCT01966718

Last Updated: 2016-08-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: From baseline to week 16
• Results posted on: 2016-08-18

Participant Flow

Participant milestones

Measure	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 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
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

Baseline characteristics by cohort

Measure	Repository Corticotropin Injection n=8 Participants 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 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	64.6 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Swollen Joints n=68 joints Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).	Tender Joints n=68 joints Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
Change From Baseline in the Ritchey-Camp Articular Index	10.25 joints Interval -1.0 to 35.0	9 joints Interval -17.0 to 31.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Swollen Joints n=8 Participants Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).	Tender Joints Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
Change From Baseline in the 20-item Health Assessment Questionnaire Score	0.03 units on a scale Interval -0.5 to 0.25	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Swollen Joints n=8 Participants Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).	Tender Joints Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)	1.9 mm/hr Interval -4.0 to 19.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Swollen Joints n=8 Participants Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).	Tender Joints Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
Change From Baseline in the C-Reactive Protein (CRP) Level	0.19 mg/dL Interval -0.3 to 0.9	—

Adverse Events

Repository Corticotropin Injection

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Repository Corticotropin Injection n=8 participants at risk 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 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
Vascular disorders Pulmonary embolism	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Vascular disorders Deep vein thrombosis	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16

Other adverse events

Measure	Repository Corticotropin Injection n=8 participants at risk 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 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
Skin and subcutaneous tissue disorders Reaction at injection site	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Endocrine disorders Hypoglycemia	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Musculoskeletal and connective tissue disorders Hip pain	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Immune system disorders Development of allergies	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Infections and infestations Pneumonia	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Cardiac disorders Atrial fibrillation	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Musculoskeletal and connective tissue disorders Fibromyalgia	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16
Cardiac disorders Hypertension	12.5% 1/8 • Number of events 1 • Collected at each visit (two to six week intervals) up to week 16

Additional Information

Dr. Nathan Wei

Arthritis Treatment Center

Phone: 301-694-5800

Email: nwei@arthritistreatmentcenter.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place