Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis

NCT07497282 | Not Yet Recruiting Phase 2

• 1 other identifier: REC # 407
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Venlafaxine; Disease activity score (DAS28); Vascular endothelial growth factor (VEGF); Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score 28 (DAS28-CRP)

  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.

  Baseline and 3 months

Secondary Outcomes (5)

• Change in C-reactive protein (CRP)

  Baseline and 3 months

• Change in erythrocyte sedimentation rate (ESR)

  Baseline and 3 months

• Change in serum vascular endothelial growth factor (VEGF)

  at baseline and after 3 months.

• safety and tolerability of venlafaxine

  at baseline and after 3 months.

• Health assessment questionnaire HAQ-DI.

  at baseline and after 3 months.

Study Arms (2)

Venlafaxine Group

EXPERIMENTAL

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)

Drug: venlafaxine extended-release (XR)

Control Group (Standard Therapy)

ACTIVE COMPARATOR

The standard treatment for Rheumatoid Arthritis, which will be maintained for the entire 12-week study period \[Standard treatment of RA includes one or more conventional DMARDs (methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) with or without low dose corticosteroids\].

Other: Standard conventional Rheumatoid Arthritis Therapy

Interventions

venlafaxine extended-release (XR) DRUG

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)

Venlafaxine Group

Standard conventional Rheumatoid Arthritis Therapy OTHER

35 patients will receive the standard treatment of RA, which will be maintained for the duration of the study (12 weeks).

Control Group (Standard Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with definite RA according to ACR/ EULAR 2010 criteria.
• Patients on stable DMARDs+/- steroid regimen for at least 6 months.
• Patients with moderate to high disease activity (DAS28 ≥ 3.2) despite treatment

You may not qualify if:

• Patients receiving biologics or targeted DMARDs
• Known hypersensitivity to venlafaxine or any of its components.
• Concurrent Use of MAOIs
• Women who are pregnant or breastfeeding.
• Uncontrolled hypertension
• Unstable Heart Conditions
• Patients receiving any other anti-depressant
• Psychiatrically unstable patients as indicated by a history of psychosis or mania, current suicidal ideation, current substance abuse or dependence.
• Renal dysfunction (creatinine clearance \<60 mL/min)
• Hepatic dysfunction (ALT and AST more than 3 times upper normal limits)
• Patients with active major bleeding or high risk of bleeding

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Arleevskaya, M., Takha, E., Petrov, S., Kazarian, G., Novikov, A., & Larionova, R. (2021). Causal risk and protective factors in rheumatoid arthritis : A genetic update. Journal of Translational Autoimmunity, 4, 100119. https://doi.org/10.1016/j.jtauto.2021.100119 BASSEL EL-ZORKANY, M.D., W. A. M. D. ., & LOBNA A. MAGED, M.D., N. E.-G. M. D. . M. (2023). Evaluation of Rheumatoid Arthritis Knowledge among a Cohort of 1004 Healthy Egyptians. The Medical Journal of Cairo University, 91(03), 225-0. https://doi.org/10.21608/mjcu.2023.307506 Bullock, J., Rizvi, A. A., Saleh, A. M., & Ahmed, S. (2018). Rheumatoid Arthritis : A Brief Overview of the Treatment. 33328, 501-507. https://doi.org/10.1159/000493390 Chen, C. Y., Yeh, Y. W., Kuo, S. C., Liang, C. S., Ho, P. S., Huang, C. C., Yen, C. H., Shyu, J. F., Lu, R. B., & Huang, S. Y. (2018). Differences in immunomodulatory properties between venlafaxine and paroxetine in patients with major depressive disorder. Psychoneuroendocrinology, 87(325), 108-118. https://doi.org/10.1016/j.psyneuen.2017.10.009 Chen, L., Zeng, X., Zhou, S., Gu, Z., & Pan, J. (2022). Correlation Between Serum Tumor Necrosis Factor-Alpha , Serum Interleukin-6 and White Matter Integrity Before and After the Treatment of Drug-Naïve Patients With Major Depressive Disorder. 16(July), 1-9. https://doi.org/10.3389/fnins.2022.948637 El Meidany, Y. M., El Gaafary, M. M., & Ahmed, I. (2003). Cross-cultural adaptation and validation of an Arabic Health Assessment Questionnaire for use in rheumatoid arthritis patients. Joint Bone Spine, 70(3), 195-202. https://doi.org/10.1016/S1297-319X(03)00004-6 F., W. (1989). The Health Assessment Questionnaire (HAQ) Disability Index (DI) Of The Clinical Health Assessment Questionnaire (Version 96.4). Arthritis Rheum., 32(Di), 2-7. Gharib, M., Elbaz, W., Darweesh, E., & Sabri, N. A. (2021). Ef fi cacy and Safety of Metformin Use in Rheumatoid Arthritis : A Randomized Controlled Study. 12(September), 1-9. https://doi.org/10.3389

  BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• sara ahmed, Bsc

  Faculty of Pharmacy, ASU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ahmed Ibrahim Ahmed, Teaching Assistant at Faculty

CONTACT

02 01016069393; Sara.ahmed18@pharma.asu.edu.eg

Hend Magraby Magraby, Associate Professor of Rheumat

CONTACT

01114911897; hendms@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teatching Assistant , Clinical Pharmacy Department

Model Details: Participants will receive venlafaxine extended-release in addition to standard rheumatoid arthritis therapy.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 27, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share