Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, Joint pain, Repository corticotropin injection
Brief summary
It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.
Detailed description
Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.
Interventions
An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances
Sponsors
Arthritis Treatment Center, Maryland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Rheumatoid arthritis of at least 2 years duration * On at least third biologic with a different mechanism of action for at least 12 weeks * Active disease as defined by at least 6 tender and 6 swollen joints * Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal * Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks
Exclusion criteria
* Prior treatment with Acthar Gel * History of intolerance or allergy to glucocorticoids * Unstable diabetes * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Ritchey-Camp Articular Index | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Repository Corticotropin Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 64.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Change From Baseline in the 20-item Health Assessment Questionnaire Score
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.
Time frame: From baseline to week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swollen Joints | Change From Baseline in the 20-item Health Assessment Questionnaire Score | 0.03 units on a scale |
Primary
Change From Baseline in the Ritchey-Camp Articular Index
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.
Time frame: From baseline to week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swollen Joints | Change From Baseline in the Ritchey-Camp Articular Index | 10.25 joints |
| Tender Joints | Change From Baseline in the Ritchey-Camp Articular Index | 9 joints |
Secondary
Change From Baseline in the C-Reactive Protein (CRP) Level
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.
Time frame: From baseline to week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swollen Joints | Change From Baseline in the C-Reactive Protein (CRP) Level | 0.19 mg/dL |
Secondary
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
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
Time frame: From baseline to week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Swollen Joints | Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) | 1.9 mm/hr |