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

NCT07726355 | Completed Phase 2

• 1 other identifier: DU- ERA 01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Rheumatoid Arthritis

Keywords

pharmacist intervention,; early rheumatoid arthiritis; DAAS 28; utility scoring

Outcome Measures

Primary Outcomes (1)

• Disease activity

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

  6 months

Study Arms (2)

intervention group

EXPERIMENTAL

Other: Clinical Pharmacist Led Intervention; Drug: DMARD Therapy

Control group

PLACEBO COMPARATOR

Drug: DMARD Therapy

Interventions

DMARD Therapy DRUG

Scheduled treatment

Control group; intervention group

Clinical Pharmacist Led Intervention OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Assiut university

Minya, Egypt

Location

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 24, 2026
• Study Start: April 10, 2025
• Primary Completion: May 10, 2026
• Study Completion: June 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

EG (1)