The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

Last updated: January 31, 2024
Sponsor: Sadat City University
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Rheumatoid Arthritis

Bone Diseases

Arthritis And Arthritic Pain

Treatment

Placebo

Paroxetine

Clinical Study ID

NCT04757571
RS10/2021
  • Ages 18-60
  • All Genders

Study Summary

Among three MAPK families, paroxetine was found to be able to decrease the phosphorylation of ERK. It was reported that paroxetine attenuates the symptoms of collage induced arthritis rats due to its inhibitory effect on T cell activation and infiltration to synovial tissue via suppression of ERK pathway. This study aimed to evaluate the therapeutic efficacy of paroxetine in rheumatoid arthritis. Paroxetine prevents the joint inflammation which is at the very early stage. paroxetine could inhibit GRK2 with selectivity over other GRKs. Medications developed for maintaining the immunologic equilibrium. such as GRK2 inhibitors, will be the novel trends in RA treatment that could avoid the adverse side effects that are common with current treatment options.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Patients with active rheumatoid arthritis based on DAS28 score. Patients received thestandard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to metformin.
  • Patients who have a prior diagnosis with diabetes mellitus.
  • Patients receive metformin for any other indications.
  • Patients with congestive heart failure.
  • Patients with a history of myocardial infarction.
  • Patients with severe anemia.
  • Patients with active infections or other inflammatory diseases.
  • Patients receiving biological therapy.
  • Pregnancy or lactation.
  • Patients with impaired liver functions.
  • Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4mg/dL in males and females respectively).
  • Patients with malignancies.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
February 01, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Faculty of Pharmacy

    Shibīn Al Kawm, Menoufia 13829
    Egypt

    Site Not Available

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