Trial · Interventional

CompletedPhase 4Results postedRegistry data

Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

NCTNCT02541955Other idActhar in Rheumatoid Arthritis

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 40 participants (actual)
Sponsor: Veena Ranganath, MD, MS · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 20 Jul 2017
Primary completion: 6 May 2025
Completion: 20 May 2025
First posted: 4 Sept 2015 (estimated)
Last update posted: 11 Aug 2026
Conditions: Rheumatoid Arthritis (RA)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph 4
Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
NCT02541955
20 Jul 2017 to 20 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

Interventions

ActharDrug

Arms2

Active comparator
40 Units
40 units of Acthar per week
Active comparator
80 Units
80 units of Acthar twice per week

Primary outcomes2

Outcomes the sponsor listed as primary.

DAS28
Time frame · Baseline to 4 Weeks
Registry description
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.
Power Doppler Ultrasound Score
Time frame · Baseline to 4 Weeks
Registry description
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.

Secondary outcomes(2)

Ultrasound Grey Scale Synovial Hypertrophy Score
Time frame · Baseline to 4 Weeks
Registry description
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.
HAQ-DI
Time frame · Baseline to 4 Weeks
Registry description
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.

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 outcomeLeast squares mean· Baseline to 4 Weeks

DAS28

Group	Value (score on a scale)
40 Units	-1.05
80 Units	-1.40

Primary outcomeLeast squares mean· Baseline to 4 Weeks

Power Doppler Ultrasound Score

Group	Value (score on a scale)
40 Units	-5.21
80 Units	-5.21

Secondary and other outcome results(2)

Secondary outcomeLeast squares mean· Baseline to 4 Weeks

Ultrasound Grey Scale Synovial Hypertrophy Score

Group	Value (score on a scale)
40 Units	-5.02
80 Units	-6.05

Secondary outcomeLeast squares mean· Baseline to 4 Weeks

HAQ-DI

Group	Value (score on a scale)
40 Units	-0.31
80 Units	-0.44

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
40 Units40 units of Acthar per week	0 / 20	0 / 20	20 / 20
80 Units80 units of Acthar twice per week	0 / 20	0 / 20	20 / 20

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Patient must meet 1987 ACR criteria 2. Age \> 18 years of age 3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) \>=3.2 4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) 5. Stable prednisone \<10mg or equivalent 6. Power Doppler score of \>=10 Exclusion Criteria: 1. Prior treatment with Acthar in the past 2mos 2. Meet one of the above RA flare requirements 3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

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