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

S

Sadat City University

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo
Drug: Paroxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT04757571
RS10/2021

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Paroxetine
Experimental group
Description:
Paroxetine 20 mg daily plus standard therapy
Treatment:
Drug: Paroxetine
Placebo
Placebo Comparator group
Description:
Placebo tablet daily plus standard therapy
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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