NCT07497282

Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis

The Effect of Venlafaxine as an Adjunct Therapy on The Clinical Outcome of Rheumatoid Arthritis Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent inflammation of the joints, leading to pain, swelling, disability, and reduced quality of life. Current therapies, although effective, may have limited efficacy or tolerability in some patients. Biological DMARDs are often associated with adverse effects, including increased risk of serious infections and heart failure. Long-term use may also increase the risk of malignancies. These limitations, together with their high cost. Venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), has shown potential anti-inflammatory properties in addition to its antidepressant effects. This study aims to evaluate the efficacy and safety of venlafaxine as an adjunct therapy in the management of rheumatoid arthritis.

Detailed description

Eligible patients will be randomly assigned using block randomization to one of the following groups: Venlafaxine group: 35 patients will receive the standard RA treatment in addition to venlafaxine extended-release (XR) initiated at a dose of 75 mg/day for one week to ensure tolerability, followed by an increase to 150 mg/day, which will be maintained for the duration of the study (12 weeks) The control group: 35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks). At baseline the following data will be collected from the patient : Age - Gender- Body mass index (BMI) - Medical history- Medication history- Smoking status- Disease duration- Dose of corticosteroids if present. Efficacy evaluation Serum CRP and ESR will be assessed at baseline and after 3 months using routine analysis • Disease activity using DAS-28-CRP Disease severity will be assessed using DAS-28-CRP at baseline and after 3 months Safety assessment All patients will be assessed on a monthly basis during clinic visits and on a weekly basis during phone calls to assess the adverse effects of venlafaxine. All patients will be educated about the study protocol and will be required to report the occurrence of any of them. Serum biomarker A blood ample will be withdrawn from each patient at baseline and after 3 month and the separated sera will be stored at -80o C till analysis. These sera will be used to assess the level of VEGF using commercial ELISA kits. Quality of life assessment using health assessment questionnaire (HAQ-DI)

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	venlafaxine extended-release (XR)	35 patients will receive the standard RA treatment in addition to venlafaxine extended-release (XR) initiated at a dose of 75 mg/day for one week to ensure tolerability, followed by an increase to 150 mg/day, which will be maintained for the duration of the study (12 weeks)
OTHER	Standard conventional Rheumatoid Arthritis Therapy	35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).

Timeline

• Start date: 2026-03-26
• Primary completion: 2026-10-26
• Completion: 2026-12-26
• First posted: 2026-03-27
• Last updated: 2026-03-27