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Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Primary Purpose

Rheumatoid Arthritis (RA)

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acthar

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid arthritis (RA), Musculoskeletal ultrasound (MSUS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must meet 1987 ACR criteria
Age > 18 years of age
Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2
Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
Stable prednisone <10mg or equivalent
Power Doppler score of >=10

Exclusion Criteria:

Prior treatment with Acthar in the past 2mos
Meet one of the above RA flare requirements
Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Sites / Locations

UCLA David Geffen School of Medicine, Division of RheumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

40 Units

80 Units

Arm Description

40 units of Acthar per week

80 units of Acthar twice per week

Outcomes

Primary Outcome Measures

Ultrasound Power Doppler Score

Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.

DAS28

DAS28 will be calculated. The change in the scores will be analyzed between the two groups.

Secondary Outcome Measures

Ultrasound Grey Scale Synovial Hypertrophy score

Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups.

HAQ-DI

Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups

Full Information

NCT ID

NCT02541955

First Posted

September 1, 2015

Last Updated

November 4, 2022

Sponsor

Veena Ranganath, MD, MS

1. Study Identification

Unique Protocol Identification Number

NCT02541955

Brief Title

Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Official Title

Use of Acthar in Rheumatoid Arthritis Related Flares

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 20, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Veena Ranganath, MD, MS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status. Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid arthritis (RA), Musculoskeletal ultrasound (MSUS)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

40 Units

Arm Type

Active Comparator

Arm Description

40 units of Acthar per week

Arm Title

80 Units

Arm Type

Active Comparator

Arm Description

80 units of Acthar twice per week

Intervention Type

Drug

Intervention Name(s)

Acthar

Other Intervention Name(s)

Repository corticotropin injection

Intervention Description

Injections will be self administered

Primary Outcome Measure Information:

Title

Ultrasound Power Doppler Score

Description

Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.

Time Frame

Baseline to 2 Weeks

Title

DAS28

Description

DAS28 will be calculated. The change in the scores will be analyzed between the two groups.

Time Frame

Baseline to 2 Weeks

Secondary Outcome Measure Information:

Title

Ultrasound Grey Scale Synovial Hypertrophy score

Description

Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups.

Time Frame

Baseline to 2 Weeks

Title

HAQ-DI

Description

Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups

Time Frame

Baseline to 4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veena K Rangantah, M.D., M.S.

Phone

310-825-3061

vranganath@mednet.ucla.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Bal-lan Yen

Phone

310-206-4112

byen@mednet.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veena K Ranganath, M.D., M.S.

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA David Geffen School of Medicine, Division of Rheumatology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veena K Ranganath, M.D.

Phone

310-825-6301

vranganath@mednet.ucla.edu

First Name & Middle Initial & Last Name & Degree

Veena K Ranganath, M.D.

First Name & Middle Initial & Last Name & Degree

Suzanne Kafaja, M.D.

12. IPD Sharing Statement

Learn more about this trial

Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

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