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Completed

NCT Number: NCT07726355

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university

Minya, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Pharmacist Led Intervention

Other

Pharmacist intervention will review patient education, Patient education, and counseling

DMARD Therapy

Drug

Scheduled treatment

Primary outcomes

  1. Disease activity

    Time frame: 6 months

    Measured using the Disease Activity Score in 28 joints (DAS28-ESR

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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