Arthritis, Rheumatoid
Conditions
Keywords
Persistent disease activity
Brief summary
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
DRUGActhar Gel
80 Units Acthar Gel per 1 mL for subcutaneous injection
DRUGPlacebo
Matching placebo 1 mL for subcutaneous injection
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part 1: Open Label ; Part 2: Double-blind
Intervention model description
Part 1: Single Group; Part 2: Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | Baseline to Week 12 | LDA is defined as DAS28 \<3.2. |
| Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | Week 12 to Week 24 | Low disease activity is defined as DAS28 \<3.2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Tender Joint Count by Visit | Baseline to Week 12 | 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 | Baseline, Week 12 to Week 24 | 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 | Baseline to Week 12 | 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 | Baseline, Week 12 to Week 24 | 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 | Baseline to Week 12 | 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: Swollen Joint Count by Visit | Baseline to Week 12 | 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: Patient's Global Assessment of Pain by Visit | Baseline to Week 12 | 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 | Baseline, Week 12 to Week 24 | 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 | Baseline to Week 12 | 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 | Week 12 to Week 24 | 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: Erythrocyte Sedimentation Rate (ESR) by Visit | Baseline, Week 12 to Week 24 | 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: Swollen Joint Count by Visit During Part 2 | Baseline, Week 12 to Week 24 | 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 |
Countries
Argentina, Mexico, Peru, Puerto Rico, United States
Participant flow
Recruitment details
A total of 259 patients were recruited at 80 study centers globally for Part 1. Of those participants, 77 were randomized to receive Acthar and 77 were randomized to receive Placebo for an additional 12 weeks, which was Part 2.
Pre-assignment details
All participants enrolled in Part 1
Participants by arm
| Arm | Count |
|---|---|
| Part 1: All Participants Enrolled All participants who enrolled in the trial | 259 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Part 1: Open Label | Adverse Event | 1 | 0 | 0 |
| Part 1: Open Label | Did Not Achieve Lda At Week 12 | 2 | 0 | 0 |
| Part 1: Open Label | did not meet inclusion criteria 8 | 1 | 0 | 0 |
| Part 1: Open Label | Dose Greater Than 20mg/Week | 1 | 0 | 0 |
| Part 1: Open Label | Lost to Follow-up | 1 | 0 | 0 |
| Part 1: Open Label | Met withdrawal criteria | 5 | 0 | 0 |
| Part 1: Open Label | Termination by Sponsor | 1 | 0 | 0 |
| Part 1: Open Label | Withdrawal by Subject | 12 | 0 | 0 |
| Part 2: Double-blind | Adverse Event | 0 | 1 | 0 |
| Part 2: Double-blind | Did not meet LDA at Week 16 | 0 | 0 | 1 |
| Part 2: Double-blind | Did not meet LDA at Week 20 | 0 | 0 | 1 |
| Part 2: Double-blind | Discontinued exclusion 16 | 0 | 0 | 2 |
| Part 2: Double-blind | Lost to Follow-up | 0 | 0 | 3 |
| Part 2: Double-blind | Met withdrawal criteria | 0 | 1 | 2 |
| Part 2: Double-blind | Withdrawal by Subject | 0 | 0 | 2 |
| Part 2: Double-blind | Worsening of disease activity | 0 | 4 | 10 |
Baseline characteristics
| Characteristic | Part 1: All Participants Enrolled |
|---|---|
| Age, Continuous | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 213 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 40 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 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 | 31 Participants |
| Race (NIH/OMB) White | 170 Participants |
| Sex: Female, Male Female | 231 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 26 / 259 | 26 / 77 | 22 / 77 |
| serious Total, serious adverse events | 3 / 259 | 0 / 77 | 0 / 77 |
Outcome results
Primary
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
LDA is defined as DAS28 \<3.2.
Time frame: Baseline to Week 12
Population: modified Intent to Treat (mITT) Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | at Baseline | 0 Participants |
| Part 1: All Participants Enrolled | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | at Week 4 | 17 Participants |
| Part 1: All Participants Enrolled | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | at Week 8 | 37 Participants |
| Part 1: All Participants Enrolled | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit | at Week 12 | 163 Participants |
p-value: =0.242One-sample binomial test
p-value: <0.0001One-sample binomial test
p-value: <0.0001One-sample binomial test
Primary
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Low disease activity is defined as DAS28 \<3.2.
Time frame: Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 12 | 77 Participants |
| Part 1: All Participants Enrolled | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 16 | 58 Participants |
| Part 1: All Participants Enrolled | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 20 | 61 Participants |
| Part 1: All Participants Enrolled | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 24 | 47 Participants |
| Part 2: Acthar Gel | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 24 | 32 Participants |
| Part 2: Acthar Gel | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 12 | 75 Participants |
| Part 2: Acthar Gel | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 20 | 48 Participants |
| Part 2: Acthar Gel | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit | at Week 16 | 53 Participants |
p-value: =0.313Pearson's Chi-square test
p-value: =0.439Pearson's Chi-square test
p-value: =0.028Pearson's Chi-square test
p-value: =0.019Pearson's Chi-square test
Secondary
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
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
Time frame: Baseline to Week 12
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | at Baseline | 43.6 mm/hr | Standard Deviation 24.77 |
| Part 1: All Participants Enrolled | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 4 | 35.4 mm/hr | Standard Deviation 23.04 |
| Part 1: All Participants Enrolled | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 8 | 30.6 mm/hr | Standard Deviation 21.24 |
| Part 1: All Participants Enrolled | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 12 | 24.0 mm/hr | Standard Deviation 21.54 |
Secondary
Part 1: Patient-Reported General Health by Visit
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.
Time frame: Baseline to Week 12
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Patient-Reported General Health by Visit | at Baseline | 59.8 mm | Standard Deviation 20.02 |
| Part 1: All Participants Enrolled | Part 1: Patient-Reported General Health by Visit | at Week 4 | 45.1 mm | Standard Deviation 23.15 |
| Part 1: All Participants Enrolled | Part 1: Patient-Reported General Health by Visit | at Week 8 | 37.8 mm | Standard Deviation 22.95 |
| Part 1: All Participants Enrolled | Part 1: Patient-Reported General Health by Visit | at Week 12 | 27.0 mm | Standard Deviation 22.18 |
Secondary
Part 1: Patient's Global Assessment of Pain by Visit
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.
Time frame: Baseline to Week 12
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Patient's Global Assessment of Pain by Visit | at Baseline | 64.9 mm | Standard Deviation 20.36 |
| Part 1: All Participants Enrolled | Part 1: Patient's Global Assessment of Pain by Visit | at Week 4 | 44.1 mm | Standard Deviation 23.78 |
| Part 1: All Participants Enrolled | Part 1: Patient's Global Assessment of Pain by Visit | at Week 8 | 37.3 mm | Standard Deviation 22.92 |
| Part 1: All Participants Enrolled | Part 1: Patient's Global Assessment of Pain by Visit | at Week 12 | 27.5 mm | Standard Deviation 23.02 |
Secondary
Part 1: Physician's Global Assessment of Disease Activities by Visit
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.
Time frame: Baseline to Week 12
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Physician's Global Assessment of Disease Activities by Visit | at Baseline | 64.3 mm | Standard Deviation 14.93 |
| Part 1: All Participants Enrolled | Part 1: Physician's Global Assessment of Disease Activities by Visit | at Week 4 | 36.1 mm | Standard Deviation 18.9 |
| Part 1: All Participants Enrolled | Part 1: Physician's Global Assessment of Disease Activities by Visit | at Week 8 | 29.0 mm | Standard Deviation 18.92 |
| Part 1: All Participants Enrolled | Part 1: Physician's Global Assessment of Disease Activities by Visit | at Week 12 | 21.0 mm | Standard Deviation 19.49 |
Secondary
Part 1: Swollen Joint Count by Visit
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
Time frame: Baseline to Week 12
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Swollen Joint Count by Visit | at Baseline | 10.9 Count of swollen joints | Standard Deviation 5.37 |
| Part 1: All Participants Enrolled | Part 1: Swollen Joint Count by Visit | at Week 4 | 5.6 Count of swollen joints | Standard Deviation 4.88 |
| Part 1: All Participants Enrolled | Part 1: Swollen Joint Count by Visit | at Week 8 | 4.0 Count of swollen joints | Standard Deviation 4.36 |
| Part 1: All Participants Enrolled | Part 1: Swollen Joint Count by Visit | at Week 12 | 2.8 Count of swollen joints | Standard Deviation 4.26 |
Secondary
Part 1: Tender Joint Count by Visit
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
Time frame: Baseline to Week 12
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 1: Tender Joint Count by Visit | at Baseline | 14.7 Count of Tender Joints | Standard Deviation 7.08 |
| Part 1: All Participants Enrolled | Part 1: Tender Joint Count by Visit | at Week 4 | 7.7 Count of Tender Joints | Standard Deviation 6.39 |
| Part 1: All Participants Enrolled | Part 1: Tender Joint Count by Visit | at Week 8 | 5.7 Count of Tender Joints | Standard Deviation 5.93 |
| Part 1: All Participants Enrolled | Part 1: Tender Joint Count by Visit | at Week 12 | 3.9 Count of Tender Joints | Standard Deviation 5.69 |
Secondary
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
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
Time frame: Baseline, Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 12 | 15.2 mm/hr | Standard Deviation 12.669 |
| Part 1: All Participants Enrolled | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 20 | 22.0 mm/hr | Standard Deviation 17.75 |
| Part 1: All Participants Enrolled | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 16 | 19.6 mm/hr | Standard Deviation 14.62 |
| Part 1: All Participants Enrolled | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 24 | 25.1 mm/hr | Standard Deviation 18.81 |
| Part 1: All Participants Enrolled | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Baseline | 42.2 mm/hr | Standard Deviation 23.05 |
| Part 2: Acthar Gel | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 24 | 23.1 mm/hr | Standard Deviation 16.56 |
| Part 2: Acthar Gel | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Baseline | 40.3 mm/hr | Standard Deviation 21.47 |
| Part 2: Acthar Gel | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 12 | 15.8 mm/hr | Standard Deviation 12.21 |
| Part 2: Acthar Gel | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 16 | 17.7 mm/hr | Standard Deviation 14.42 |
| Part 2: Acthar Gel | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit | at Week 20 | 17.5 mm/hr | Standard Deviation 13.67 |
Secondary
Part 2: Patient-Reported General Health by Visit
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.
Time frame: Baseline, Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Patient-Reported General Health by Visit | at Week 12 | 15.4 mm | Standard Deviation 14.47 |
| Part 1: All Participants Enrolled | Part 2: Patient-Reported General Health by Visit | at Week 20 | 18.5 mm | Standard Deviation 20.14 |
| Part 1: All Participants Enrolled | Part 2: Patient-Reported General Health by Visit | at Week 16 | 17.2 mm | Standard Deviation 18.16 |
| Part 1: All Participants Enrolled | Part 2: Patient-Reported General Health by Visit | at Week 24 | 21.4 mm | Standard Deviation 22.56 |
| Part 1: All Participants Enrolled | Part 2: Patient-Reported General Health by Visit | at Baseline | 13.5 mm | Standard Deviation 7.24 |
| Part 2: Acthar Gel | Part 2: Patient-Reported General Health by Visit | at Week 24 | 21.3 mm | Standard Deviation 21.28 |
| Part 2: Acthar Gel | Part 2: Patient-Reported General Health by Visit | at Baseline | 13.5 mm | Standard Deviation 6.41 |
| Part 2: Acthar Gel | Part 2: Patient-Reported General Health by Visit | at Week 12 | 18.8 mm | Standard Deviation 14.34 |
| Part 2: Acthar Gel | Part 2: Patient-Reported General Health by Visit | at Week 16 | 19.6 mm | Standard Deviation 17.98 |
| Part 2: Acthar Gel | Part 2: Patient-Reported General Health by Visit | at Week 20 | 17.9 mm | Standard Deviation 16.04 |
Secondary
Part 2: Patient's Global Assessment of Pain by Visit
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.
Time frame: Baseline, Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Patient's Global Assessment of Pain by Visit | at Week 12 | 17.0 mm | Standard Deviation 16 |
| Part 1: All Participants Enrolled | Part 2: Patient's Global Assessment of Pain by Visit | at Week 20 | 20.0 mm | Standard Deviation 20.21 |
| Part 1: All Participants Enrolled | Part 2: Patient's Global Assessment of Pain by Visit | at Week 16 | 21.6 mm | Standard Deviation 21.72 |
| Part 1: All Participants Enrolled | Part 2: Patient's Global Assessment of Pain by Visit | at Week 24 | 22.1 mm | Standard Deviation 20.5 |
| Part 1: All Participants Enrolled | Part 2: Patient's Global Assessment of Pain by Visit | at Baseline | 62.8 mm | Standard Deviation 21.02 |
| Part 2: Acthar Gel | Part 2: Patient's Global Assessment of Pain by Visit | at Week 24 | 21.8 mm | Standard Deviation 19.7 |
| Part 2: Acthar Gel | Part 2: Patient's Global Assessment of Pain by Visit | at Baseline | 65.7 mm | Standard Deviation 18.65 |
| Part 2: Acthar Gel | Part 2: Patient's Global Assessment of Pain by Visit | at Week 12 | 18.9 mm | Standard Deviation 16.64 |
| Part 2: Acthar Gel | Part 2: Patient's Global Assessment of Pain by Visit | at Week 16 | 22.1 mm | Standard Deviation 20.77 |
| Part 2: Acthar Gel | Part 2: Patient's Global Assessment of Pain by Visit | at Week 20 | 19.8 mm | Standard Deviation 16.23 |
Secondary
Part 2: Physician's Global Assessment of Disease Activities by Visit
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.
Time frame: Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 12 | 11.5 mm | Standard Deviation 8.91 |
| Part 1: All Participants Enrolled | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 16 | 15.5 mm | Standard Deviation 15.57 |
| Part 1: All Participants Enrolled | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 20 | 15.9 mm | Standard Deviation 16.25 |
| Part 1: All Participants Enrolled | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 24 | 17.8 mm | Standard Deviation 18.12 |
| Part 2: Acthar Gel | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 24 | 15.2 mm | Standard Deviation 16.84 |
| Part 2: Acthar Gel | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 12 | 12.9 mm | Standard Deviation 11.49 |
| Part 2: Acthar Gel | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 20 | 12.4 mm | Standard Deviation 8.61 |
| Part 2: Acthar Gel | Part 2: Physician's Global Assessment of Disease Activities by Visit | at Week 16 | 13.3 mm | Standard Deviation 13.78 |
Secondary
Part 2: Swollen Joint Count by Visit During Part 2
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
Time frame: Baseline, Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 12 | 0.9 Count of swollen joints | Standard Deviation 1.09 |
| Part 1: All Participants Enrolled | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 20 | 1.9 Count of swollen joints | Standard Deviation 3.62 |
| Part 1: All Participants Enrolled | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 16 | 1.7 Count of swollen joints | Standard Deviation 3.08 |
| Part 1: All Participants Enrolled | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 24 | 2.3 Count of swollen joints | Standard Deviation 3.71 |
| Part 1: All Participants Enrolled | Part 2: Swollen Joint Count by Visit During Part 2 | at Baseline | 10.1 Count of swollen joints | Standard Deviation 4.87 |
| Part 2: Acthar Gel | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 24 | 1.5 Count of swollen joints | Standard Deviation 2.29 |
| Part 2: Acthar Gel | Part 2: Swollen Joint Count by Visit During Part 2 | at Baseline | 9.7 Count of swollen joints | Standard Deviation 4.32 |
| Part 2: Acthar Gel | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 12 | 0.9 Count of swollen joints | Standard Deviation 1.03 |
| Part 2: Acthar Gel | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 16 | 1.1 Count of swollen joints | Standard Deviation 1.31 |
| Part 2: Acthar Gel | Part 2: Swollen Joint Count by Visit During Part 2 | at Week 20 | 0.9 Count of swollen joints | Standard Deviation 1.19 |
Secondary
Part 2: Tender Joint Count by Visit
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
Time frame: Baseline, Week 12 to Week 24
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: All Participants Enrolled | Part 2: Tender Joint Count by Visit | at Week 12 | 1.5 Count of Tender Joints | Standard Deviation 1.33 |
| Part 1: All Participants Enrolled | Part 2: Tender Joint Count by Visit | at Week 20 | 2.7 Count of Tender Joints | Standard Deviation 4.36 |
| Part 1: All Participants Enrolled | Part 2: Tender Joint Count by Visit | at Week 16 | 2.6 Count of Tender Joints | Standard Deviation 3.96 |
| Part 1: All Participants Enrolled | Part 2: Tender Joint Count by Visit | at Week 24 | 3.1 Count of Tender Joints | Standard Deviation 4.46 |
| Part 1: All Participants Enrolled | Part 2: Tender Joint Count by Visit | at Baseline | 13.5 Count of Tender Joints | Standard Deviation 7.24 |
| Part 2: Acthar Gel | Part 2: Tender Joint Count by Visit | at Week 24 | 2.4 Count of Tender Joints | Standard Deviation 4.29 |
| Part 2: Acthar Gel | Part 2: Tender Joint Count by Visit | at Baseline | 13.5 Count of Tender Joints | Standard Deviation 6.41 |
| Part 2: Acthar Gel | Part 2: Tender Joint Count by Visit | at Week 12 | 1.4 Count of Tender Joints | Standard Deviation 1.24 |
| Part 2: Acthar Gel | Part 2: Tender Joint Count by Visit | at Week 16 | 1.6 Count of Tender Joints | Standard Deviation 1.47 |
| Part 2: Acthar Gel | Part 2: Tender Joint Count by Visit | at Week 20 | 1.5 Count of Tender Joints | Standard Deviation 1.67 |