Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Refractory rheumatoid arthritis patients
You will not qualify if you...
- Other connective tissue diseases
- Endocrine diseases such as DM and thyroid disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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