NCT06456489

Brief Summary

Remission or low disease activity in active rheumatoid arthritis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 1, 2024

Last Update Submit

June 7, 2024

Conditions

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • remission or low disease activity

    Outcome measurements for both groups will be done at baseline and every month for 3 months. DAS28, DAS28 ESR ACR20 ACR50 ACR70

    4 months

Study Arms (2)

pulse steroid solumedrol

EXPERIMENTAL

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

Drug: Solumedrol

without pulse

PLACEBO COMPARATOR

patients will not receive any additional treatment

Drug: Solumedrol

Interventions

SolumedrolDRUG

125 mg methylprednisolone intravenous pulse on 2 consecutive days

pulse steroid solumedrolwithout pulse

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory rheumatoid arthritis patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar Univrsity

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 13, 2024

Study Start

May 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

EG(1)