Rheumatoid ArthritisNCT05267431
Outcomes of Biological Therapy on Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Sohag University at 1 site in Egypt.
Trial summary
Evaluate effect of biological therapy on activity of RA compared to usual DMARDs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Biological Drug
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA patients
Who may be able to join
- RA patients
Who cannot join
- any other connective tissue disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag faculty of medicine
Sohag, Sohag Governorate
N M, 01004517558, nesmamansour971@yahoo.com
About this study
Official title: Outcomes of Different Biological Therapy on Rheumatoid Arthritis
Evaluate effect of biological therapy on activity of RA compared to usual DMARDs
Read the detailed description
Comparison between RA activity in both groups who recieved biological and DMARDS therapy
- Conditions
- Rheumatoid Arthritis
- Being tested
- Biological Drug
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological DrugDrug
Also called DMARDS as hydroquinone and methotrexate
Different biological drugs
| Study group | Role | What they receive |
|---|---|---|
| RA patients recieved biological therapy | RA patients recieved different biological therapy | |
| RA patients recieved different DMARDS | RA patients recieved different DMARDS Receives: Drug: Biological Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity of rheumatoid arthritis
By DAS 28; it include 28 tender and swollen joints, laboratory test (ESR) and visual analogue score, if it higher than 5.1 it mean high disease activity and if lower than 3.2 it mean low activity and consider remission if lower than 2.6
Measured: After 3 months of treatment
Secondary outcomes (1)
Activity of RA
MHAQ.scores include questionnaire from eight activities of daily living and range from 0 to 3 and lower scores mean better function state and high scores mean worse function state
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mansour Mohamed, Sohag University
- Investigators
- N M AHM, Specialist, Principal investigator, Sohag faculty of medicineM M AHM, Principal investigator, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267431
- Sponsor's protocol ID
- Soh-Med-22-02-16
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Different Biological Therapy on Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05267431
- Acronym / sponsor ID
- Soh-Med-22-02-16
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 4 Mar 2022 (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.
Evaluate effect of biological therapy on activity of RA compared to usual DMARDs
Detailed description
Comparison between RA activity in both groups who recieved biological and DMARDS therapy
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients recieved biological therapy | – | –RA patients recieved different biological therapy |
| RA patients recieved different DMARDS | – | Drug: Biological DrugRA patients recieved different DMARDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients
Key inclusion criteria (1 listed)
- RA patients
Key exclusion criteria (1 listed)
- any other connective tissue disease
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 |
|---|---|---|
| Biological DrugAlso: DMARDS as hydroquinone and methotrexateDifferent biological drugs | Drug | RA patients recieved different DMARDS |
Primary outcome
Change in activity of rheumatoid arthritis
Time frame: After 3 months of treatment
By DAS 28; it include 28 tender and swollen joints, laboratory test (ESR) and visual analogue score, if it higher than 5.1 it mean high disease activity and if lower than 3.2 it mean low activity and consider remission if lower than 2.6
1 secondary outcome
Activity of RA
Time frame: 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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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.
N M AHM, Specialist principal investigator
Sohag faculty of medicine
M M AHM principal investigator
Sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 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 21 Mar 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact N M Mansour (01004517558, nesmamansour971@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in activity of rheumatoid arthritis (time frame: After 3 months of treatment). 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 21 Mar 2022.