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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03511625
Date of registration: 10/04/2018
Prospective Registration: Yes
Primary sponsor: Attune Health Research, Inc.
Public title: The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
Scientific title: The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
Date of first enrolment: October 2, 2018
Target sample size: 6
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03511625
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Swamy R Venuturupalli, MD, FACR
Address: 
Telephone:
Email:
Affiliation:  CEO
Key inclusion & exclusion criteria

Inclusion Criteria:

- Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis

- on a stable regimen of medications

- moderate to severe disease activity as measured by the Clinical Disease activity index
(CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study

- Patients must have at least one joint with the following features within 30 days of
starting the study:

1. Joint must be tender

2. Joint must be swollen

3. Joint must have +2 or +3 doppler signal by ultrasound exam

4. Joint must have +2 or +3 gray scale synovitis by ultrasound exam e. Joint must be
amenable to synovial biopsy.

f. Clinician assessing the joint must conclude, with a reasonable degree of certainty,
that the swelling and tenderness observed in the joint is caused by rheumatoid
arthritis, and not by another arthritic condition such as osteoarthritis, crystal
arthritis, or infection.

Exclusion Criteria:

- Patients on anti-coagulation therapy

- Patients with an active infection

- Patients receiving oral corticosteroids within 5 days of enrollment, or parenteral
corticosteroids within 3 weeks of enrollment (unless deemed able to taper off
medication under investigator oversight and supervision)

- Patients with any history of joint infection

- Patients with a history of tuberculosis or coccidioidomycosis



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Acthar Injectable Product
Drug: Depo medrol
Primary Outcome(s)
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment [Time Frame: Samples collected about 30 minutes before first treatment injection and about five days after this first injection]
Initial degree of inflammation, as measured by a pathologist during histological assessment [Time Frame: Samples collected about five days after first injection of treatment]
Secondary Outcome(s)
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) [Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.]
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) [Time Frame: Assessments are performed about 5 days after first treatment injection]
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment [Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.]
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment [Time Frame: Assessments are performed about 5 days after first treatment injection]
Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score) [Time Frame: Assessments are performed about 1 hour before first treatment injection]
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) [Time Frame: Assessments are performed about 1 hour before first treatment injection]
Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints [Time Frame: Assessments are performed about 1 hour before first treatment injection]
Initial patient global health assessment measured by the patient (from 0=best to 100=worst) [Time Frame: Assessments are performed about 1 hour before first treatment injection]
Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints [Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.]
Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints [Time Frame: Assessments are performed about 5 days after first treatment injection]
Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment [Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.]
Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment [Time Frame: Assessments are performed about 5 days after first treatment injection]
Secondary ID(s)
32971
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Mallinckrodt
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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