Low-dose Interleukin-2 Treatment on Polymyalgia Rheumatica

NCT04062006 | Unknown Phase 2

• 1 other identifier: 2019-PHB089-03
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) on polymyalgia rheumatica.

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

• Foxp3+Treg cells: change in percentage of total lymphocytes

  Treg refers to regulatory T cells

  week 12

Secondary Outcomes (7)

• Physician's Global Disease Activity VAS

  week12 and 24

• Patient's Global Disease Activity VAS

  week12 and 24

• Safety and tolerability of interleukin-2 as assessed by incidence of adverse events reported and observed

  up to 24 weeks

• Patient reported outcome 36-item Short Form Health Survey (SF-36)

  wee12 and 24

• Proportion of patients with Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg

  from week 0 to week 12 and 24

Study Arms (1)

Interleukin-2

EXPERIMENTAL

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU/m2 five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10\~6 IU/m2 five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).

Also known as: Recombinant Human Interleukin-2

Interleukin-2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥50 years at screening visits
• Diagnostics meet the 1986 Nancy recommendations
• Apply glucocorticoids (≤10 mg/d prednisone or equivalent doses of other hormones), DMARDs (eg methotrexate, hydroxychloroquine, azathioprine, morphine, Ester, leflunomide, cyclosporine, etc.) must be stable for 4 weeks and do not increase hormone doses or other immunosuppressive agents throughout the study. If the enrolled doctor plans to stop using the current immunosuppressant or glucocorticoid, the elution period needs to be followed before enrollment. Each drug needs to meet the following elution period
• Glucocorticoid-2 weeks
• Immunosuppressants (including methotrexate, azathioprine, cyclosporine, tacrolimus, leflunomide, mycophenolate mofetil) - 4 weeks
• Intravenous immunogloblin (IVIg) or cyclophosphamide - 2 months
• Rituximab - 6 months
• Other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) -12 weeks
• The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
• Excluding Horton syndrome
• The amount of non-steroidal dose was stable 4 weeks before enrollment

You may not qualify if:

• Any subject meeting any of the following criteria should be excluded:
• Use rituximab or other monoclonal antibodies within 6 months.
• Received high doses of glucocorticoid (\>10 mg/d) within 1 month.
• Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit)
• Other serious, progressive or uncontrollable hematology, gastrointestinal, endocrine, pulmonary, cardiac, neurological or brain disorders (including demyelinating diseases such as multiple sclerosis).
• Known allergies, hyperreactivity or intolerance of IL-2 or its excipients.
• Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
• Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months prior to the first use of the study drug.
• Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
• Any known history of malignancy in the past 5 years (except for non-melanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
• Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
• Accept or expect to receive any live virus or bacterial vaccination within 3 months prior to the first injection of the study agent, during the study period, or within 4 months after the last injection of the study agent. Bacillus Calmette-Guerin (BCG) vaccine was inoculated within 12 months after screening.
• Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
• Men whose partners have fertility potential but are reluctant to use appropriate medically-accepted contraceptives during treatment and 12 months after the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (3)

• Kermani TA, Warrington KJ. Advances and challenges in the diagnosis and treatment of polymyalgia rheumatica. Ther Adv Musculoskelet Dis. 2014 Feb;6(1):8-19. doi: 10.1177/1759720X13512450.

  PMID: 24489611 RESULT

• Brooks RC, McGee SR. Diagnostic dilemmas in polymyalgia rheumatica. Arch Intern Med. 1997 Jan 27;157(2):162-8.

  PMID: 9009973 RESULT

• Bird HA, Esselinckx W, Dixon AS, Mowat AG, Wood PH. An evaluation of criteria for polymyalgia rheumatica. Ann Rheum Dis. 1979 Oct;38(5):434-9. doi: 10.1136/ard.38.5.434.

  PMID: 518143 RESULT

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 20, 2019
• Study Start: August 31, 2019
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share