Primary outcomeCount of participants· Baseline to Week 12
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
| Group | Value (Participants) |
|---|---|
| Part 1: All Participants Enrolled | 0 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataSafety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
NCTNCT02919761 (opens ClinicalTrials.gov in a new tab)Other idMNK14294063
This trial does not test a peptide that PepBank tracks.
- Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 259 participants (actual)
- Sponsor
- Mallinckrodt · Industry
- Design
- Randomized · Double masking
- Countries
5 countries
United States, Argentina, Mexico, Peru, Puerto Rico
- Start
- 7 Nov 2016
- Primary completion
- 17 Oct 2018
- Completion
- 13 Feb 2019
- First posted
- 29 Sept 2016 (estimated)
- Last update posted
- 31 Mar 2020
- Conditions
- Arthritis, Rheumatoid
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20162017201820192020
- Ph 4
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
NCT029197617 Nov 2016 to 13 Feb 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.
Interventions
- Acthar GelDrug
- PlaceboDrug
Arms3
Experimental
Part 1: All Enrolled Participants
All participants receive Acthar Gel 1 mL twice weekly for 12 weeks
Experimental
Part 2: Acthar Gel
Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
Placebo comparator
Part 2: Placebo
Participants receive Placebo 1 mL twice weekly for an additional 12 weeks
Primary outcomes2
Outcomes the sponsor listed as primary.
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
Time frame · Baseline to Week 12
Registry description
LDA is defined as DAS28 \<3.2.
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Time frame · Week 12 to Week 24
Registry description
Low disease activity is defined as DAS28 \<3.2.
Secondary outcomes(12)
Part 1: Swollen Joint Count by Visit
Time frame · Baseline to Week 12
Registry description
The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 2: Swollen Joint Count by Visit During Part 2
Time frame · Baseline, Week 12 to Week 24
Registry description
The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28) The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 1: Tender Joint Count by Visit
Time frame · Baseline to Week 12
Registry description
The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 2: Tender Joint Count by Visit
Time frame · Baseline, Week 12 to Week 24
Registry description
The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28) The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 1: Patient-Reported General Health by Visit
Time frame · Baseline to Week 12
Registry description
Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health.
Part 2: Patient-Reported General Health by Visit
Time frame · Baseline, Week 12 to Week 24
Registry description
Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health. A lower score indicates better general health.
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
Time frame · Baseline to Week 12
Registry description
The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
Time frame · Baseline, Week 12 to Week 24
Registry description
The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour. The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr). The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females. The ESR is a common test for inflammation and used to derive the DAS28. The DAS28 is a composite score derived from the following assessments: * Swollen Joint Count * Tender Joint Count * Patient's Global Health * Erythrocyte Sedimentation Rate
Part 1: Patient's Global Assessment of Pain by Visit
Time frame · Baseline to Week 12
Registry description
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Part 2: Patient's Global Assessment of Pain by Visit
Time frame · Baseline, Week 12 to Week 24
Registry description
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.
Part 1: Physician's Global Assessment of Disease Activities by Visit
Time frame · Baseline to Week 12
Registry description
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Part 2: Physician's Global Assessment of Disease Activities by Visit
Time frame · Week 12 to Week 24
Registry description
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· Week 12 to Week 24
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
| Group | Value (Participants) |
|---|---|
| Part 2: Placebo | 77 |
| Part 2: Acthar Gel | 75 |
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline to Week 12
Part 1: Swollen Joint Count by Visit
| Group | Value (Count of swollen joints) | Spread |
|---|---|---|
| Part 1: All Participants Enrolled | 10.9 | 5.37 |
Secondary outcomeMean· Baseline, Week 12 to Week 24
Part 2: Swollen Joint Count by Visit During Part 2
| Group | Value (Count of swollen joints) | Spread |
|---|---|---|
| Part 2: Placebo | 10.1 | 4.87 |
| Part 2: Acthar Gel | 9.7 | 4.32 |
Secondary outcomeMean· Baseline to Week 12
Part 1: Tender Joint Count by Visit
| Group | Value (Count of Tender Joints) | Spread |
|---|---|---|
| Part 1: All Participants Enrolled | 14.7 | 7.08 |
Secondary outcomeMean· Baseline, Week 12 to Week 24
Part 2: Tender Joint Count by Visit
| Group | Value (Count of Tender Joints) | Spread |
|---|---|---|
| Part 2: Placebo | 13.5 | 7.24 |
| Part 2: Acthar Gel | 13.5 | 6.41 |
Secondary outcomeMean· Baseline to Week 12
Part 1: Patient-Reported General Health by Visit
| Group | Value (mm) | Spread |
|---|---|---|
| Part 1: All Participants Enrolled | 59.8 | 20.02 |
Secondary outcomeMean· Baseline, Week 12 to Week 24
Part 2: Patient-Reported General Health by Visit
| Group | Value (mm) | Spread |
|---|---|---|
| Part 2: Placebo | 13.5 | 7.24 |
| Part 2: Acthar Gel | 13.5 | 6.41 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part 1: All Participants EnrolledAll participants enrolled in the trial with AEs during Part 1 | 0 / 259 | 3 / 259 | 26 / 259 |
| Part 2: PlaceboParticipants who received Placebo in Part 2 with AEs during Part 2 | 0 / 77 | 0 / 77 | 26 / 77 |
| Part 2: Acthar GelParticipants who received Acthar Gel in Part 2 with AEs during Part 2 | 0 / 77 | 0 / 77 | 22 / 77 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
PubMed tag: none · 2020
5 results
Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial.
Fleischmann et al. 2020Rheumatology and therapycited by 26
PMID 32185745PMC7211215DOI 10.1007/s40744-020-00199-3PUB-32185745
Free to read · publisher termsCC BY-NC5 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedFleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16. PMID 32497440
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or nonpregnant, nonlactating female subjects
* Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
* Has active disease defined as a score of \>3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
* Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
* May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration
Exclusion Criteria:
* Has current rheumatoid disease or inflammatory joint disease other than RA
* Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
* Has taken B-cell mediated therapies in the 6 months prior to screening
* Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
* Has history of Type 1 or Type 2 diabetes
* Has any clinically significant infection
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