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Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents

The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011772
Enrollment
Unknown
Registered
2017-06-28
Start date
2017-06-27
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral
Control group:Traditional DMARDs group

Sponsors

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old, male or female; 2. meet ACR / EULAR 2010 RA classification criteria and scoring system; 3. the disease is active: (1) DAS28 score> 2.6; (2) conventional treatment for more than 3 months do not ease; 4. screening of the subjects must meet the following laboratory inspection requirements: (1) Hb85g / L; WBC 4*10^9/L; neutrophil count 1.5*10^9/L; platelet 100*10^9/L; (2) transaminase normal upper limit of 1.5 times; creatinine 120mol/L (1.4 mg/dl); 5. Th17 is higher than the normal range; or Treg is below the normal range; or Th17/Treg is elevated; 6. Pregnancy tests for women of childbearing age were negative and agreed to take effective contraceptive measures during the trial period and within 6 months after the end of the trial; 7. subjects can be regularly referral.

Exclusion criteria

Exclusion criteria: (1) disabled, bed rest, wheelchair dependent, life can not take care of themselves; (2) suffering from systemic inflammatory disease, the symptoms and signs are expected to affect the evaluation of the test drug, such as: SLE and other rheumatic diseases; (3) screening within 5 years before or now suffering from malignant tumors; a history of chronic infection, nearly 2 months of a serious history of infection or nearly 6 months had chance of infection; currently suffering from active hepatitis or C History of hepatitis; HIV infection; such as lymphoma and other lymphoproliferative diseases; have multiple sclerosis or other central nervous demyelinating disease; have or now suffering from congestive heart failure; have serious, progressive Skin, lung, kidney, kidney, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerve and brain; pure protein derivative (PPD) skin test positive or (and) X-ray showed lung There are signs of infection or close contact with tuberculosis patients; (4) 4 weeks participated in other drug observers or recently used other biological agents.

Design outcomes

Primary

MeasureTime frame
Peripheral blood Th17, Treg cells absolute count and the proportion,DAS28 score;

Secondary

MeasureTime frame
Swollen joints, number of pain joints, ESR, CRP, IgS, joint color Doppler ultrasound, HAQ score;

Countries

China

Contacts

Public ContactWang Yongfu

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital

18047211500@163.com+86 18047211500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026