Actively Recruiting

Phase 3
Age: 20Years - 65Years
All Genders
ID06456489

Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis

Led by Sohag University · Updated on 2024-06-13

268

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of intravenous pulse steroid therapy on patients with active rheumatoid arthritis who have not responded well to other treatments. The study focuses on achieving remission or low disease activity, using measures such as the Disease Activity Score (DAS28), erythrocyte sedimentation rate (ESR), and American College of Rheumatology (ACR) 20, 50, and 70 scores. These assessments will help understand how well the treatment works for this condition. Participants will be randomly assigned to one of two groups. One group will receive 125 mg of methylprednisolone administered intravenously on two consecutive days, followed by a two-week course of oral steroids with gradual withdrawal. The other group will not receive any additional treatment. The study is conducted in a single-blind manner and will last for four months, with monthly evaluations. During the study, patients will be monitored monthly through clinical assessments to track disease activity and response to treatment. These evaluations include scoring systems that measure joint inflammation and patient symptoms. Researchers will closely observe remission or low disease activity as the primary outcome at four months. The study is sponsored by Sohag University and aims to provide detailed data on steroid pulse therapy in this patient group.

CONDITIONS

Brief Title

Pulse Steroid Injection in Refractory Rheumatoid Arthritis

Who Can Participate

Age: 20Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Refractory rheumatoid arthritis patients
Not Eligible

You will not qualify if you...

  • Other connective tissue diseases
  • Endocrine diseases such as DM and thyroid disorders

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive intravenous pulse steroid therapy followed by oral steroids with gradual withdrawal, or no additional treatment if assigned to placebo.

1 visit for intravenous pulses on 2 consecutive days and follow-up visits up to 2 weeks

Follow-up

Duration - 3 months

Participants are assessed monthly for 3 consecutive months to monitor rheumatoid arthritis activity and response to treatment.

Monthly visits for 3 months

Trial Site Locations

Total: 1 location

1

Al-Azhar Univrsity

Cairo, Egypt

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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