Clinical trial

The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.

Name
RS10/2021
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Paroxetine
Paroxetine 20 mg tablet plus standard therapy
Arms:
Paroxetine
Placebo
Placebo tablet plus standard therapy
Arms:
Placebo
Size
100
Primary endpoint
ACR 20% improvement criteria (ACR20) response rate
week 12
ACR50 & ACR70 response rate
week 12
Disease activity scale in 28 joints (DAS-28)
week 12
Eligibility criteria
Inclusion Criteria: • Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months. 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 ≥1.4 mg/dL in males and females respectively). * Patients with malignancies.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-02-01

1 organization

2 products

1 indication

Product
Paroxetine
Product
Placebo