Clinical trial NCT03511625: The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
Official title: The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Attune Health Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mallinckrodt
First posted: 2018-04-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.

Detailed description: Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment. At screening visit, inclusion and exclusion criteria will be assessed. If assessments have not been completed to verify these criteria, they will be performed at this visit. After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection. About 5 days after this first treatment injection, these assessment and samples will be performed again. About 5-6 weeks after first treatment injection, a final physician assessment will be performed. Patients will have the option of consenting to allow storage of samples for future research.

Eligibility 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

Primary outcomes:
measure: Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
timeFrame: Samples collected about 30 minutes before first treatment injection and about five days after this first injection
measure: Initial degree of inflammation, as measured by a pathologist during histological assessment
timeFrame: Samples collected about five days after first injection of treatment
Secondary outcomes:
measure: Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)
timeFrame: Assessments are performed about 1 hour before first treatment injection
measure: Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
timeFrame: Assessments are performed about 5 days after first treatment injection
measure: Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
timeFrame: Assessments are performed about 5-6 weeks after first treatment injection.
measure: Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints
timeFrame: Assessments are performed about 1 hour before first treatment injection
measure: Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints
timeFrame: Assessments are performed about 5 days after first treatment injection
measure: Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints
timeFrame: Assessments are performed about 5-6 weeks after first treatment injection.
measure: Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)
timeFrame: Assessments are performed about 1 hour before first treatment injection
measure: Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment
timeFrame: Assessments are performed about 5 days after first treatment injection
measure: Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment
timeFrame: Assessments are performed about 5-6 weeks after first treatment injection.
measure: Initial patient global health assessment measured by the patient (from 0=best to 100=worst)
timeFrame: Assessments are performed about 1 hour before first treatment injection
measure: Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment
timeFrame: Assessments are performed about 5 days after first treatment injection
measure: Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment
timeFrame: Assessments are performed about 5-6 weeks after first treatment injection.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Attune Health
state: California
Study officials:
affiliation: CEO
name: Swamy R Venuturupalli, MD, FACR
role: PRINCIPAL_INVESTIGATOR
References: