Rheumatoid ArthritisNCT03999528
14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Osteoporosis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoporosis
- What is being tested?
- 14-3-3η Protein assay
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Aug 2019
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with rheumatoid arthritis attending the Rheumatology department, at Al-Azhar faculty of medicine from May 2019 to August 2019
Who may be able to join
- Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
- Premenopausal females.
- On conventional DMARD with maximum 5 mg steroids.
Who cannot join
- Biological treatment.
- Previous antiresorptive treatment, or bone anabolics.
- High dose corticosteroid.
- Chronic renal or kidney disease.
- Medications affecting bone metabolism.
- Thyroid or adrenal dysfunction,
Trial locations and contacts
1 site in 1 country.
About this study
Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.
Read the detailed description
Methods: all patients in the study will subject to:
- Clinical assessment, WT, Height ,BMI, parity, medications,
- DAS 28.
- Serum 14-3-3η protein.
- DEXA scan.
Grouping:
- Group I: RA Patients with low BMD.
- Group II: RA Patients with normal BMD.
- Group III: normal control.
- Conditions
- Rheumatoid Arthritis, Osteoporosis
- Being tested
- 14-3-3η Protein assay
- Keywords
- 14-3-3η Protein
- Medical subject headings
- Arthritis, Rheumatoid, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-3-3η Protein assayDiagnostic test
blood sampling for assessment of serum 14-3-3η Protein
| Study group | Role | What they receive |
|---|---|---|
| study group | RA Patients Receives: Diagnostic Test: 14-3-3η Protein assay | |
| control group | normal control Receives: Diagnostic Test: 14-3-3η Protein assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-3-3η Protein and RA disease activity
percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity
Measured: three months
Secondary outcomes (1)
14-3-3η Protein and osteoporosis in RA patients
percent of low BMD and study the correlation between 14-3-3η Protein and osteoporosis in RA patients
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 May 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
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 Al-Azhar 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abogamal, Al-Azhar University
- Investigators
- AHMED ABOGAMAL, Study chair, Al-Azhar Faculty of medicine- Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999528
- Sponsor's protocol ID
- Rheu-med.9med.research
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03999528
- Acronym / sponsor ID
- Rheu-med.9med.research
- Conditions
- Rheumatoid Arthritis, Osteoporosis
- Keywords
- 14-3-3η Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 26 Jun 2019 (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.
Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.
Detailed description
Methods: all patients in the study will subject to:
- Clinical assessment, WT, Height ,BMI, parity, medications,
- DAS 28.
- Serum 14-3-3η protein.
- DEXA scan.
Grouping:
- Group I: RA Patients with low BMD.
- Group II: RA Patients with normal BMD.
- Group III: normal control.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: 14-3-3η Protein assayRA Patients |
| control group | – | Diagnostic Test: 14-3-3η Protein assaynormal control |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with rheumatoid arthritis attending the Rheumatology department, at Al-Azhar faculty of medicine from May 2019 to August 2019
Key inclusion criteria (3 listed)
- Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
- Premenopausal females.
- On conventional DMARD with maximum 5 mg steroids.
Key exclusion criteria (6 listed)
- Biological treatment.
- Previous antiresorptive treatment, or bone anabolics.
- High dose corticosteroid.
- Chronic renal or kidney disease.
- Medications affecting bone metabolism.
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 |
|---|---|---|
| 14-3-3η Protein assayblood sampling for assessment of serum 14-3-3η Protein | Diagnostic test | control group, study group |
Primary outcome
14-3-3η Protein and RA disease activity
Time frame: three months
percent of active RA disease and study the correlation between 14-3-3η Protein and RA disease activity
1 secondary outcome
14-3-3η Protein and osteoporosis in RA patients
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- 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.
AHMED ABOGAMAL study chair
Al-Azhar Faculty of medicine- Cairo
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 and Osteoporosis, run by Al-Azhar 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-3-3η Protein and RA disease activity (time frame: three 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 9 Jun 2020.