Active Rheumatoid ArthritisPhase 3NCT06456489
Pulse Steroid Injection in Refractory Rheumatoid Arthritis
A Phase 3 study testing Solumedrol in people with Active Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Remission or low disease activity in active rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Solumedrol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Phase 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory rheumatoid arthritis patients
Who cannot join
- Other connective tissue diseases
- Endocrine diseases such as DM and thyroid disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar Univrsity
Cairo
Al-Azhar Universiy, 01026912179, info@azharegypt.net
Al-Azhar Universiy
About this study
Official title: Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis
Remission or low disease activity in active rheumatoid arthritis
Read the detailed description
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
- Active Rheumatoid Arthritis
- Being tested
- Solumedrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolumedrolDrug
125 mg methylprednisolone intravenous pulse on 2 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Solumedrol |
| without pulse | Placebo comparator | patients will not receive any additional treatment Receives: Drug: Solumedrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 May 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456489
- Sponsor's protocol ID
- Al-Azhar University
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06456489
- Acronym / sponsor ID
- Al-Azhar University
- Conditions
- Active Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
Remission or low disease activity in active rheumatoid arthritis
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulse steroid solumedrol | Experimental | Drug: Solumedrol125 mg of methylprednisolone IV pulse will be administered for two consecutive days followed by oral steroid for 2 weeks with gradual withdrawal. |
| without pulse | Placebo comparator | Drug: Solumedrolpatients will not receive any additional treatment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Refractory rheumatoid arthritis patients
Key exclusion criteria (2 listed)
- Other connective tissue diseases
- Endocrine diseases such as DM and thyroid disorders
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 |
|---|---|---|
| Solumedrol125 mg methylprednisolone intravenous pulse on 2 consecutive days | Drug | pulse steroid solumedrol, without pulse |
Primary outcome
remission or low disease activity
Time frame: 4 months
Outcome measurements for both groups will be done at baseline and every month for 3 months. DAS28, DAS28 ESR ACR20 ACR50 ACR70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solumedrol in people with Active Rheumatoid Arthritis, run by Sohag 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission or low disease activity (time frame: 4 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 13 Jun 2024.