Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02467504
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: Peking University People's Hospital
• Public title: Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis
• Scientific title: A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis
• Date of first enrolment: July 1, 2015
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02467504
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Zhanguo Li, MD PhD
• Affiliation: Peking University Institute of Rheuamotology and Immunology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female =18 and =70 years of age at time of screening

- Diagnosed with rheumatoid arthritis

- Must have active disease with DMARDs (Disease Modifying Anti-Rheumatic Drugs) except
MTX, the doses had been stable for at least 3 months before baseline

- Moderate or severe rheumatoid arthritis during screening, as defined by a disease
activity score (28 joint) calculated using the C-reactive protein formula (DAS28-ESR)
> 3.2

- Have given written informed consent

Exclusion Criteria:

- Patient presenting or having a history of other inflammatory joint disease

- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis
or erythema multiforme

- Patient with significantly impaired bone marrow function or significant anaemia,
leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis

- Persistent infection or severe infection within 3 months before enrollment,

- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease,
active inflammatory bowel disease, active peptic ulcer disease, terminal illness or
other medical condition which, in the opinion of the investigator, would put the
patient at risk to participate in the study,

- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
systemic disease making implementation of the protocol or interpretation of the study
results difficult

- Severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome)
with serum albumin < 30 g/L

- Moderate or severe impairment of renal function, as known by serum creatinine >
133µmol/L (or 1.5 mg/dl)

- Patient with history of recent and clinically significant drug or alcohol abuse

- Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold
the upper limit of normal

- Known HIV positive status

- Known positive serology for hepatitis B or C

- Patient with hypersensitivity to any of the excipients in the tablets of methotrexate

- Pregnancy

- Breastfeeding

- Women of childbearing potential, except if they fulfill specific conditions,

- Men wishing to father children during the course of the study or within the 24 months
thereafter (or 3 month with the washout procedure)

- Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or
lymphoproliferative disease, or any patient who has received total lymphoid
irradiation.

- Enrollment in any other clinical trial involving off-label use of an investigational
drug or device, or enrollment in any other type of medical research

- Any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 28 days prior to first investigational product
dose

- BMI(body mass index) under 18.5 kg/m2 or more than 30 kg/m2

- The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: hrIL-2 active

Drug: hrIL-2 placebo

Drug: Folic Acid

Drug: Loxoprofen

Drug: MTX

Primary Outcome(s)

Percentage of Participants Achieving DAS28 Remission. [Time Frame: week 24]

Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria [Time Frame: week 12, week 24]

The Change From Baseline of Simplified Disease Activity Index (SDAI) [Time Frame: week 12, week 24]

The Change From Baseline of Clinical Disease Activity Index (CDAI) [Time Frame: week 12, week 24]

Secondary Outcome(s)

The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA) [Time Frame: week 12, week 24]

C Reactive Protein (CRP) [Time Frame: week 12, week 24]

The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI) [Time Frame: week 12, week 24]

Percentage of CD4+ Treg Cells [Time Frame: week 12, week 24]

Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice [Time Frame: week 12, week 24]

The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA) [Time Frame: week 12, week 24]

Work Productivity Survey - Rheumatoid Arthritis [WPS-RA] [Time Frame: week 24]

Number of Participants With Adverse Events [Time Frame: Up to week 24]

Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response [Time Frame: week 12, week 24]

Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria [Time Frame: week 12, week 24]

Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria [Time Frame: week 12, week 24]

Percentage of Participants Achieving DAS28 Low Disease Activity. [Time Frame: week 12, week 24]

The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP) [Time Frame: week 12, week 24]

The Scores of SF-36 Quetionnaire [Time Frame: week 12, week 24]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: week 12, week 24]

Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2 [Time Frame: week 24]

Secondary ID(s)

hrIL-2 RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing ShuangLu Pharmaceutical Co., Ltd.

Monash University

Results

• Results available: Yes
• Date Posted: 09/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02467504