Pulse Steroid Injection in Refractory Rheumatoid Arthritis

NCT ID: NCT06456489

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-12-31

Brief Summary

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Remission or low disease activity in active rheumatoid arthritis

Detailed Description

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Assessment of rheumatoid arthritis activity by Disease activity score DAS28, DAS28 Erythrocyte sedimentation rate (ESR), American college of rheumatology (ACR) 20, ACR 50, ACR 70 will be done at baseline and every month for 3 consecutive months for both groups.

Conditions

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Active Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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pulse steroid solumedrol

125 mg of methylprednisolone IV pulse will be administered for two consecutive days followed by oral steroid for 2 weeks with gradual withdrawal.

Group Type EXPERIMENTAL

Solumedrol

Intervention Type DRUG

125 mg methylprednisolone intravenous pulse on 2 consecutive days

without pulse

patients will not receive any additional treatment

Group Type PLACEBO_COMPARATOR

Solumedrol

Intervention Type DRUG

125 mg methylprednisolone intravenous pulse on 2 consecutive days

Interventions

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Solumedrol

125 mg methylprednisolone intravenous pulse on 2 consecutive days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Refractory rheumatoid arthritis patients

Exclusion Criteria

* Other connective tissue diseases
* Endocrine diseases such as DM and thyroid disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar Univrsity

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Al-Azhar Universiy

Role: primary

01026912179

Al-Azhar Universiy

Role: backup

Other Identifiers

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Al-Azhar University

Identifier Type: -

Identifier Source: org_study_id

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