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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTHAR Gel | Other | Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTHAR gel | Drug | Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry W Moreland, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
No patients were excluded from the study based on enrollment criteria. Because ACTHAR administration was add on therapy, no wash out period was required.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Study completers (9/13 had evaluable data at baseline and week 12) | Posted | Count of Participants | Participants | 12 weeks |
|
Adverse events were collected over a 16 week period spanning from baseline to 16 weeks
No deviation from standard adverse events definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rib fractures | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | ATV accident resulting in multiple rib fractures |
This trial was limited by small sample size and reduced number of participants completing the study. Statistical analysis was compromised by missing standard-of-care laboratory values.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dana Ascherman (Principal Investigator) | University of Pittsburgh | 14123838123 | DAscher@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2022 | Aug 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2020 | Jun 22, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| 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)) |
| 12 weeks |
| 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) | 12 weeks |
| 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. | 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Erythrocyte Sedimentation Rate (ESR) | scale: 0 - >120 mm/hr (normal range 0-20) | Mean | Standard Deviation | mm/hr |
|
| C-Reactive Protein (CRP) | scale: continuous measure of serum C-Reactive Protein concentration from 0 mg/dl, with undefined upper limit (normal range 0-0.8 mg/dl) | Mean | Standard Deviation | mg/dl |
|
| Tender Joints | scale: 0-28 joints | Median | Inter-Quartile Range | joints |
|
| Swollen Joints | scale: 0-28 joints | Median | Inter-Quartile Range | joints |
|
| Physician Global Assessment of Disease Activity | scale: 0-10 cm (0=no disease activity, 10=maximal disease activity) | Median | Inter-Quartile Range | units on a scale |
|
| Patient Global Assessment of Disease Activity | scale: 0-10 cm (0=no disease activity, 10=maximal disease activity) | Median | Inter-Quartile Range | units on a scale |
|
| CDAI (Clinical Disease Activity Index) | scale: 0-76 based on composite of tender joint count (0-28), swollen joint count (0-28), patient global disease activity (0-10 cm), and physician global disease activity (0-10 cm). Higher numbers indicate greater/more severe disease activity. | Median | Inter-Quartile Range | units on a scale |
|
| DAS28-ESR (Disease Activity Score 28--ESR) | scale: based on composite of tender joints (0-28), swollen joints (0-28), patient assessment of disease activity (0-100 mm), and ESR (0 - >120) calculation of total score based on formula: 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR) Total score range: 0 (minimum) to 9.2 (maximum); remission: < 2.6 low disease activity: 2.6-3.1 moderate disease activity: 3.1-5.1 high disease activity: >5.1 | Mean | Standard Deviation | units on a scale |
|
| DAS28-CRP (Disease Activity Score 28--CRP) | scale: based on composite of tender joints (0-28), swollen joints (0-28), patient assessment of disease activity (0-100 mm), and CRP (0 - 150) calculation of total score based on formula: (0.56 × √TJC) + (0.28 × √SJC) + (0.014 × PGA [mm]) + (0.36 × ln(CRP in mg/L+1) + 0.96 Range of total score: 0 (minimum) to 8.61 (maximum); remission: < 2.5 low disease activity: 2.5-2.9 moderate disease activity: 2.9-4.6 high disease activity: >4.6 | Mean | Standard Deviation | units on a scale |
|
| fatigue severity scale--functional well-being subscale | scale: 0-28 based on 0 (not fatigued)-4 (very fatigued) Likert scale within 7 domains/questions; 0=limited fatigue, 28=high level of fatigue | Median | Inter-Quartile Range | units on a scale |
|
| FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale: 0-52 based on 0 (not fatigued)-4 (very fatigued) Likert scale within 13 domains/questions; 0=limited fatigue, 52=high level of fatigue | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | Study completers--5/13 with evaluable data | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 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)) | Study completers--7/13 with evaluable data | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| 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) | Study completers--8/13 with evaluable data | Posted | Mean | Standard Deviation | mm/hr | 12 weeks |
|
|
|
| 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. | Study completers--13/13 with evaluable data | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |