Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, ACTH gel
Brief summary
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.
Detailed description
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.
Interventions
DRUGACTHAR gel
Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
Sponsors
Mallinckrodt
Dana Ascherman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 18 year of age and older * RA diagnosis by American College of Rheumatology criteria * Active disease (CDAI \> 10) * Have received at least are biologic agent for at least 6 months * May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent * No current active infections requiring antibiotics * Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)
Exclusion criteria
* Less than 18 years of age * Unable or unwilling to give Informed Consent * Have an active infection requiring the use of antibiotics * Women who are pregnant * Uncontrolled hypertension * Abnormal renal function * Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 | 12 weeks | percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 | 12 weeks | Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement. Scale: 0-8.61 (lower scores indicate reduced disease activity) |
| Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 | 12 weeks | Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP \< 0)) |
| Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 | 12 weeks | Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS \< 0) |
| Patient Reported Changes in Fatigue Between Week 0 and Week 12 | 12 weeks | The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue. |
Countries
United States
Participant flow
Pre-assignment details
No patients were excluded from the study based on enrollment criteria. Because ACTHAR administration was add on therapy, no wash out period was required.
Participants by arm
| Arm | Count |
|---|---|
| ACTHAR Gel Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
ACTHAR gel: Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | lack of transportation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | ACTHAR Gel |
|---|---|
| Age, Continuous | 55.3 years |
| CDAI (Clinical Disease Activity Index) | 27 units on a scale |
| C-Reactive Protein (CRP) | 0.42 mg/dl STANDARD_DEVIATION 0.33 |
| DAS28-CRP (Disease Activity Score 28--CRP) | 4.2 units on a scale STANDARD_DEVIATION 0.6 |
| DAS28-ESR (Disease Activity Score 28--ESR) | 5.6 units on a scale STANDARD_DEVIATION 1.6 |
| Erythrocyte Sedimentation Rate (ESR) | 37.2 mm/hr STANDARD_DEVIATION 33.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale | 26 units on a scale |
| fatigue severity scale--functional well-being subscale | 13 units on a scale |
| Patient Global Assessment of Disease Activity | 7 units on a scale |
| Physician Global Assessment of Disease Activity | 5 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 1 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 2 Participants |
| Swollen Joints | 6 joints |
| Tender Joints | 6 joints |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
Time frame: 12 weeks
Population: Study completers (9/13 had evaluable data at baseline and week 12)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACTHAR Gel | Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 | 8 Participants |
Secondary
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS \< 0)
Time frame: 12 weeks
Population: Study completers--8/13 with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACTHAR Gel | Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 | -7.38 mm/hr | Standard Deviation 28.3 |
Secondary
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement. Scale: 0-8.61 (lower scores indicate reduced disease activity)
Time frame: 12 weeks
Population: Study completers--5/13 with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACTHAR Gel | Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 | -0.87 units on a scale | Standard Deviation 1.75 |
Secondary
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP \< 0))
Time frame: 12 weeks
Population: Study completers--7/13 with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACTHAR Gel | Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 | 0.36 mg/dl | Standard Deviation 1.33 |
Secondary
Patient Reported Changes in Fatigue Between Week 0 and Week 12
The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.
Time frame: 12 weeks
Population: Study completers--13/13 with evaluable data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACTHAR Gel | Patient Reported Changes in Fatigue Between Week 0 and Week 12 | -3.8 units on a scale |