The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

NCT03511625 | Unknown Phase 3 FDA Drug

• 1 other identifier: 32971
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment

  Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.

  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

  Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.

  Samples collected about five days after first injection of treatment

Secondary Outcomes (12)

• Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)

  Assessments are performed about 1 hour before first treatment injection

• Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)

  Assessments are performed about 5 days after first treatment injection

• Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)

  Assessments are performed about 5-6 weeks after first treatment injection.

• Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints

  Assessments are performed about 1 hour before first treatment injection

• Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints

  Assessments are performed about 5 days after first treatment injection

Study Arms (2)

Acthar

EXPERIMENTAL

80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.

Drug: Acthar Injectable Product

Depo Medrol

ACTIVE COMPARATOR

40 milligrams of Depo Medrol will be injected intramuscularly one time

Drug: Depo medrol

Interventions

Acthar Injectable Product DRUG

Acthar is a non-specific melanocortin receptor agonist

Also known as: repository corticotropin injection, H.P. Acthar Gel

Acthar

Depo medrol DRUG

Depo medrol is an anti-inflammatory glucocorticoid

Also known as: methylprednisolone acetate injectable suspension

Depo Medrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Joint must be tender
• Joint must be swollen
• Joint must have +2 or +3 doppler signal by ultrasound exam
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Attune Health Research, Inc.: lead
• Mallinckrodt: collaborator

Study Sites (1)

Attune Health

Beverly Hills, California, 90211, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Swamy R Venuturupalli, MD, FACR

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 30, 2018
• Study Start: October 2, 2018
• Primary Completion: February 26, 2020
• Study Completion: December 3, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (1)