NCT Number: NCT07497282
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
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
Serum biomarker A blood ample will be withdrawn from each patient at baseline and after 3 month and the separated sera will be stored at -80o C till analysis.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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).
Time frame: Baseline and 3 months
Disease severity will be assessed using DAS-28-CRP Disease activity will be assessed using the Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP), a validated composite index that includes tender joint count (28 joints), swollen joint count (28 joints), C-reactive protein (CRP), and patient global assessment of health.
The DAS28-CRP score ranges approximately from 0 to 9.4, with higher scores indicating higher disease activity and worse outcomes.
Time frame: Baseline and 3 months
Serum C-reactive protein (CRP) levels will be measured as an indicator of systemic inflammation.
CRP is expressed in mg/L, with higher values indicating increased inflammatory activity.
Time frame: Baseline and 3 months
Erythrocyte sedimentation rate (ESR) will be measured as a marker of inflammation.
ESR is expressed in mm/hour, with higher values indicating increased inflammatory activity.
Time frame: at baseline and after 3 months.
To investigate the change in serum vascular endothelial growth factor (VEGF) levels before and after venlafaxine treatment.
A blood sample 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.
Time frame: at baseline and after 3 months.
To evaluate the safety and tolerability of venlafaxine through monitoring and documentation of potential adverse events during the study period
Time frame: at baseline and after 3 months.
It consists of 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2-3 questions per domain.
Each question is scored from 0 (no difficulty) to 3 (unable to do). The domain score is determined by the highest response within that domain. If an assistive device or help from another person is required, the minimum score for that domain is 2 (unless the score is already ≥ 2).
The total HAQ-DI score is calculated by summing the 8 domain scores and dividing by 8. The final score ranges from 0 to 3, with higher scores indicating greater disability.
Contact information is provided by the study sponsor or research team.
Hend Magraby Magraby, Associate Professor of Rheumat
CONTACT
Sara Ahmed Ibrahim Ahmed, Teaching Assistant at Faculty
CONTACT
Ain Shams University
Other
The Effect of Venlafaxine as an Adjunct Therapy on The Clinical Outcome of Rheumatoid Arthritis Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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