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A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid Arthritis

NCT07726355

CompletedPhase 2, Phase 3

Sponsor: Deraya University

Conditions: Early Rheumatoid Arthritis

Interventions: Clinical Pharmacist Led Intervention, DMARD Therapy

Countries: Egypt

Background: Rheumatoid arthritis (RA) is a progressive chronic autoimmune disease with a rising global burden, in which early diagnosis and timely therapeutic intervention are critical to preventing irreversible joint damage and preserving long-term function. Despite established treat-to-target (T2T) frameworks-incorporating conventional, biological, and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) and endorsed by the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR)-a substantial proportion of patients with early RA fail to achieve the recommended target of DAS28 \<2.6 (remission) or 2.6-3.2 (low disease activity), reflecting persistent gaps in disease management. Pharmacological therapy alone is insufficient: adherence barriers, inadequate disease knowledge, psychosocial distress, unresolved medication-related problems, and suboptimal monitoring continue to undermine outcomes. Clinical pharmacists, whose scope of practice has expanded substantially beyond dispensing to encompass medication optimization, patient education, and behavioral support, represent an underutilized resource in rheumatology care. Purpose: This narrative review synthesizes available evidence on the impact of clinical pharmacist-led interventions on disease activity (DAS28), medication adherence, functional disability, and quality of life (QoL) outcomes in patients with early RA, with particular attention to non-pharmacological mechanisms of effect and the role of adherence as a core mediating outcome.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients aged 18-65 years.
* Diagnosis of early RA according to the 2010 ACR/EULAR classification criteria.
* Disease lasts less than 2 years.
* Presence of at least one tender and one swollen joint.
* Ability to provide informed consent.

Exclusion Criteria:

* Use of oral glucocorticoids \>10 mg/day during the previous 3 weeks.
* Current biological DMARD therapy.
* AST or ALT \>3 times the upper limit of normal.
* eGFR \<30 mL/min/1.73 m².
* Active infection.
* Malignancy.
* Pregnancy or lactation.
* Other autoimmune or musculoskeletal disorders.
* Inability to participate in follow-up.

Locations (1)

Minya, Egypt