Early Rheumatoid ArthritisPhase 2/3NCT07726355
A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid Arthritis
A Phase 2/3 study testing Clinical Pharmacist Led Intervention and DMARD Therapy in people with Early Rheumatoid Arthritis, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Rheumatoid Arthritis
- What is being tested?
- Clinical Pharmacist Led Intervention and DMARD Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 1 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy or lactation.
- Other autoimmune or musculoskeletal disorders.
- Inability to participate in follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Clinical Pharmacist Led Intervention, DMARD Therapy
- Keywords
- pharmacist intervention,, early rheumatoid arthiritis, DAAS 28, utility scoring
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist Led InterventionOther
Pharmacist intervention will review patient education, Patient education, and counseling
DMARD TherapyDrug
Scheduled treatment
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Clinical Pharmacist Led Intervention; Drug: DMARD Therapy |
| Control group | Placebo comparator | Not described Receives: Drug: DMARD Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
Measured using the Disease Activity Score in 28 joints (DAS28-ESR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Apr 2025
- Primary completion10 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726355
- Sponsor's protocol ID
- DU- ERA 01
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07726355
- Acronym / sponsor ID
- DU- ERA 01
- Conditions
- Early Rheumatoid Arthritis
- Keywords
- pharmacist intervention,, early rheumatoid arthiritis, DAAS 28, utility scoring
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Clinical Pharmacist Led Intervention, Drug: DMARD Therapy |
| Control group | Placebo comparator | Drug: DMARD Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pharmacist Led InterventionPharmacist intervention will review patient education, Patient education, and counseling | Other | intervention group |
| DMARD TherapyScheduled treatment | Drug | Control group, intervention group |
Primary outcome
Disease activity
Time frame: 6 months
Measured using the Disease Activity Score in 28 joints (DAS28-ESR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clinical Pharmacist Led Intervention and DMARD Therapy in people with Early Rheumatoid Arthritis, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.