Rheumatoid ArthritisGITRNCT03763201
Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Benha University at 1 site in Egypt.
Trial summary
This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- measurement of GITR
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2018to 15 Sep 2020
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex matched)
Who may be able to join
- fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed
Who cannot join
- infection malignancy receiving treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
bENHA UNIVERSITY HOSPITAL
Banhā, Qalyubia Governorate, 13518
Ali Fouda, MD, 00201066640220, ali71960@hotmail.com
Waleed A Hassan, MD, 00201095000886, waleed22101979@yahoo.com
About this study
Official title: Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients
This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy
Read the detailed description
- Technical design: Study design: a longitudinal observational cohort study. This study will be carried out on two groups:
- Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010 American college of rheumatology (ACR) - European league against rheumatism (EULAR) classification criteria for RA [11].
- Group (II): Twenty healthy individuals of matching age and sex as control group. Both groups will be recruited from the in-patients and out-patients' clinic of the Rheumatology, Rehabilitation\& Physical Medicine Department, Benha University Hospital. All patients will be evaluated at baseline at 6 months follow up using: (A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3. Disease activity using DAS28 [12] (B) Laboratory assessment: All patients will be subjected to the following measurements:
- Erythrocyte sedimentation rate (ESR).
- C reactive protein (CRP).
- Rheumatoid factor (RF)
- Anti-cyclic citrullinated peptide (Anti- CCP).
- glucocorticoid-induced tumour necrosis factor receptor related protein (GITR) (D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz linear transducer
- Statistical analysis The collected data will be tabulated and analyzed using suitable statistical computer version.
- Conditions
- Rheumatoid Arthritis
- Being tested
- measurement of GITR
- Keywords
- Rheumatoid arthritis, glucocorticoid-induced tumour necrosis factor receptor related protein
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of GITRDiagnostic test
serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis | recently diagnosed rheumatoid arthritis patients in whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum and synovial fluid (if clinically determined knee effusion) Receives: Diagnostic Test: measurement of GITR | |
| control group | age and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum. Receives: Diagnostic Test: measurement of GITR |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 tender joints count
tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
Measured: 4 months
28 swollen joints count
swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
Measured: 4 months
patient's global assessment of disease activity
patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
Measured: 4 months
disease activity score of 28 joint count (DAS28)
DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * global patient assesment
Measured: 4 months
erythrocyte sedimentation rate (ESR)
ESR measured in mm/1st hour by westergren method
Measured: 4 months
C reactive protein (CRP)
CRP measured in mg/L using nephlometry
Measured: 4 months
grey scale12 joint score
grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule.
Measured: 4 months
power Doppler 12 joint score
power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area.
Measured: 4 months
rheumatoid factor
rheumatoid factor measured in U/ml using latex agglutination test
Measured: 4 months
anticyclic citrullinated antibody (Anti CCP)
Anti CCP measured in Unit/ml using ELISA
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 posted4 Dec 2018
- Study start8 Nov 2018
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2020 (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 Benha 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Waleed A Hassan, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763201
- Sponsor's protocol ID
- BenhaU 112018
- Acronym
- GITR
- Status last verified
- Jul 2020
- First submitted
- 29 Nov 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) as a Marker of Activity in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT03763201
- Acronym / sponsor ID
- GITR / BenhaU 112018
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, glucocorticoid-induced tumour necrosis factor receptor related protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 4 Dec 2018 (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.
This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy
Detailed description
- Technical design: Study design: a longitudinal observational cohort study. This study will be carried out on two groups:
- Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010 American college of rheumatology (ACR) - European league against rheumatism (EULAR) classification criteria for RA [11].
- Group (II): Twenty healthy individuals of matching age and sex as control group. Both groups will be recruited from the in-patients and out-patients' clinic of the Rheumatology, Rehabilitation\& Physical Medicine Department, Benha University Hospital. All patients will be evaluated at baseline at 6 months follow up using: (A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3. Disease activity using DAS28 [12] (B) Laboratory assessment: All patients will be subjected to the following measurements:
- Erythrocyte sedimentation rate (ESR).
- C reactive protein (CRP).
- Rheumatoid factor (RF)
- Anti-cyclic citrullinated peptide (Anti- CCP).
- glucocorticoid-induced tumour necrosis factor receptor related protein (GITR) (D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz linear transducer
- Statistical analysis The collected data will be tabulated and analyzed using suitable statistical computer version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis | – | Diagnostic Test: measurement of GITRrecently diagnosed rheumatoid arthritis patients in whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum and synovial fluid (if clinically determined knee effusion) |
| control group | – | Diagnostic Test: measurement of GITRage and sex matched healthy volunteers whom we measure Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in their serum. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2 groups: first: recently diagnosed RA patients 2nd : healthy control ( age and sex matched)
Key inclusion criteria (1 listed)
- fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed
Key exclusion criteria (1 listed)
- infection malignancy receiving treatment
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 |
|---|---|---|
| measurement of GITRserum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein | Diagnostic test | control group, rheumatoid arthritis |
Primary outcome
28 tender joints count
Time frame: 4 months
tender joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
28 swollen joints count
Time frame: 4 months
swollen joints count of both shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees in Rheumatoid patients
patient's global assessment of disease activity
Time frame: 4 months
patient's global assessment of disease activity on 0 to 100 mm VAS 0 is the best and 100 is the worst.
disease activity score of 28 joint count (DAS28)
Time frame: 4 months
DAS28 is calculated from tender and swollen joint counts , ESR and patient's global assessment of disease activity according to the following formula DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * global patient assesment
erythrocyte sedimentation rate (ESR)
Time frame: 4 months
ESR measured in mm/1st hour by westergren method
C reactive protein (CRP)
Time frame: 4 months
CRP measured in mg/L using nephlometry
grey scale12 joint score
Time frame: 4 months
grey scale musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following greyscale synovitis semiquantitative grades were assumed: Grade 0: absent. Grade 1: mild with anechoic / hypoechoic line below the capsule of the joint. Grade 2: moderate with elevation of the joint capsule that becomes parallel to the area of the joint. Grade 3: severe with marked distension of the capsule.
power Doppler 12 joint score
Time frame: 4 months
power Doppler musculoskeletal ultrasound including bilateral examination of both 2nd metacarpophalengeal (MCP) joints, 3rd MCP joints, wrists, elbows, knees and ankles then the following power Doppler synovitis grades were assumed: Grade 0: no colour signal inside joint area. Grade 1: up to 3 colour signals inside joint area. Grade 2: colour signals less than half of joint area and more than grade 1. Grade 3: colour signals more than half of joint area.
rheumatoid factor
Time frame: 4 months
rheumatoid factor measured in U/ml using latex agglutination test
anticyclic citrullinated antibody (Anti CCP)
Time frame: 4 months
Anti CCP measured in Unit/ml using ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
Waleed A Hassan, MD principal investigator
Benha university- Qaluibya- Egypt
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 Benha 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 7 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed A Hassan, MD (02 01095000886, waleed22101979@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 tender joints count (time frame: 4 months). The study lists 10 primary outcomes in all. 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 7 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.