Trial Outcomes & Findings for Use of Acthar in Rheumatoid Arthritis (RA) Related Flares (NCT NCT02541955)
NCT ID: NCT02541955
Last Updated: 2026-08-11
Results Overview
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Baseline to 4 Weeks
Results posted on
2026-08-11
Participant Flow
Participant milestones
| Measure |
40 Units
40 units of Acthar per week
|
80 Units
80 units of Acthar twice per week
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
Baseline characteristics by cohort
| Measure |
40 Units
n=20 Participants
40 units of Acthar per week
|
80 Units
n=20 Participants
80 units of Acthar twice per week
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
|
2 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
5 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 14.00 • n=54 Participants
|
56.2 Years
STANDARD_DEVIATION 15.15 • n=54 Participants
|
52.2 Years
STANDARD_DEVIATION 14.96 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=54 Participants
|
18 Participants
n=54 Participants
|
37 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic White
|
5 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
6 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or Pacific Islander
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic Black
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian / Alaskan Native
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Prefer Not to Say
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 WeeksPopulation: One patient in the 80 unit group only had baseline data and was not included in the model
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6.
Outcome measures
| Measure |
40 Units
n=20 Participants
40 units of Acthar per week
|
80 Units
n=19 Participants
80 units of Acthar twice per week
|
|---|---|---|
|
DAS28
|
-1.05 score on a scale
Interval -1.51 to -0.59
|
-1.40 score on a scale
Interval -1.86 to -0.93
|
PRIMARY outcome
Timeframe: Baseline to 4 WeeksPopulation: One patient in the 80 unit group only had baseline data and was not included in the model
34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.
Outcome measures
| Measure |
40 Units
n=20 Participants
40 units of Acthar per week
|
80 Units
n=19 Participants
80 units of Acthar twice per week
|
|---|---|---|
|
Power Doppler Ultrasound Score
|
-5.21 score on a scale
Interval -8.66 to -1.76
|
-5.21 score on a scale
Interval -8.76 to -1.67
|
SECONDARY outcome
Timeframe: Baseline to 4 WeeksPopulation: One patient in the 80 unit group only had baseline data and was not included in the model
34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level.
Outcome measures
| Measure |
40 Units
n=20 Participants
40 units of Acthar per week
|
80 Units
n=19 Participants
80 units of Acthar twice per week
|
|---|---|---|
|
Ultrasound Grey Scale Synovial Hypertrophy Score
|
-5.02 score on a scale
Interval -8.76 to -1.28
|
-6.05 score on a scale
Interval -9.89 to -2.2
|
SECONDARY outcome
Timeframe: Baseline to 4 WeeksPopulation: One patient in the 80 unit group only had baseline data and was not included in the model
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0, with higher scores indicating worse function.
Outcome measures
| Measure |
40 Units
n=20 Participants
40 units of Acthar per week
|
80 Units
n=19 Participants
80 units of Acthar twice per week
|
|---|---|---|
|
HAQ-DI
|
-0.31 score on a scale
Interval -0.5 to -0.12
|
-0.44 score on a scale
Interval -0.63 to -0.24
|
Adverse Events
40 Units
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
80 Units
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
40 Units
n=20 participants at risk
40 units of Acthar per week
|
80 Units
n=20 participants at risk
80 units of Acthar twice per week
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
JOINT PAIN
|
30.0%
6/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Surgical and medical procedures
NAIL PROCEDURE
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Gastrointestinal disorders
NAUSEA
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Cardiac disorders
POSTURAL ORTHOSTATIC TACHYCARDIA
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
15.0%
3/20 • From baseline through 12 weeks
All enrolled patients
|
|
Skin and subcutaneous tissue disorders
THROMBOPHLEBITIS
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Renal and urinary disorders
URINARY SYMPTOMS
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Skin and subcutaneous tissue disorders
BRUISING
|
20.0%
4/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Nervous system disorders
SYNCOPE (VASOVAGAL)
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
MUSCLE PAIN
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Nervous system disorders
PARESTHESIA
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
15.0%
3/20 • From baseline through 12 weeks
All enrolled patients
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS FLARE
|
35.0%
7/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFECTION
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
25.0%
5/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
DRY MOUTH
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Investigations
ELEVATED C-REACTIVE PROTEIN
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Cardiac disorders
HYPERTENSION
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Investigations
HYPOALBUMINEMIA
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
NIGHT SWEATS
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
ANXIETY
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Infections and infestations
ASYMPTOMATIC BACTERIURIA
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Skin and subcutaneous tissue disorders
ATOPIC DERMATITIS
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
BRAIN FOG
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Injury, poisoning and procedural complications
BURN
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Cardiac disorders
CHEST PAIN
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Surgical and medical procedures
DENTAL PROCEDURE
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
DEPRESSED MOOD
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Gastrointestinal disorders
DIARRHEA
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
EDEMA
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Musculoskeletal and connective tissue disorders
ENTHESITIS
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
HOT FLASHES
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Eye disorders
INFLAMMATORY EYE DISORDER
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Immune system disorders
Allergies
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Investigations
Anemia
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
20.0%
4/20 • From baseline through 12 weeks
All enrolled patients
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
Fatigue
|
20.0%
4/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Nervous system disorders
Headache/Migraine
|
40.0%
8/20 • From baseline through 12 weeks
All enrolled patients
|
0.00%
0/20 • From baseline through 12 weeks
All enrolled patients
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
General disorders
Injection Site Reaction
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
20.0%
4/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
Irritability
|
15.0%
3/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Investigations
Leukocytosis
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
|
Psychiatric disorders
Mood Disturbance
|
10.0%
2/20 • From baseline through 12 weeks
All enrolled patients
|
5.0%
1/20 • From baseline through 12 weeks
All enrolled patients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place