Rheumatoid ArthritisNCT04415502
CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 May 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Measuring of CTHRc1 levels and its correlation with RA disease activity
Who may be able to join
- patients diagnosed as RA
- age more than 18 years
Who cannot join
- other rheumatological diseases Malignancies Hepatic diseases
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Recently, reported increased levels of collagen triple helix repeat containing 1 protein (CTHRC1) are strongly associated with the severity of murine proteoglycan-induced arthritis and collagen antibody-induced murine arthritis (CAIA) , further CTHRC1 expression in murine experimental arthritis is increased in the synovium and specifically detected in activated murine , located at the synovial intimal lining and at the bone-pannus interface .Of interest,The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients .
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Measuring of CTHRc1 , its correlation with RAdisease activity | Measuring of CTHRc1 levels and its correlation with RA disease activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTHRC1 in RA
Measuring of CTHRc1 in Rheumatoid arthritis patients.
Measured: One year
CTHRc1 and RA disease activity
Correlation of CTHRc1levels with RA disease activity
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Amer Araby Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415502
- Sponsor's protocol ID
- CTHRC1 in RA
- Status last verified
- Jun 2020
- First submitted
- 31 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chewick S. Infection control demand administrative support. Dimens Health Serv. 1975 Dec;52(12):40-1. No abstract available.
PubMed 1305Lumholtz IB. [Nurses' drug information: therapeutic action group: benzodiazepine derivatives. 2]. Sygeplejersken. 1975 Sep 24;75(38):15. No abstract available. Danish.
PubMed 803
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity
- ClinicalTrials.gov ID
- NCT04415502
- Acronym / sponsor ID
- CTHRC1 in RA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity
Detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Recently, reported increased levels of collagen triple helix repeat containing 1 protein (CTHRC1) are strongly associated with the severity of murine proteoglycan-induced arthritis and collagen antibody-induced murine arthritis (CAIA) , further CTHRC1 expression in murine experimental arthritis is increased in the synovium and specifically detected in activated murine , located at the synovial intimal lining and at the bone-pannus interface .Of interest,The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measuring of CTHRc1 , its correlation with RAdisease activity | – | –Measuring of CTHRc1 levels and its correlation with RA disease activity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Measuring of CTHRc1 levels and its correlation with RA disease activity
Key inclusion criteria (2 listed)
- patients diagnosed as RA
- age more than 18 years
Key exclusion criteria (1 listed)
- other rheumatological diseases Malignancies Hepatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CTHRC1 in RA
Time frame: One year
Measuring of CTHRc1 in Rheumatoid arthritis patients.
CTHRc1 and RA disease activity
Time frame: One year
Correlation of CTHRc1levels with RA disease activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 1305Chewick S. Infection control demand administrative support. Dimens Health Serv. 1975 Dec;52(12):40-1. No abstract available.
- Background: PubMed 803Lumholtz IB. [Nurses' drug information: therapeutic action group: benzodiazepine derivatives. 2]. Sygeplejersken. 1975 Sep 24;75(38):15. No abstract available. Danish.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
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 2 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Lobna Amer Araby Ahmed, Master (01019313530, Lobnaamer20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTHRC1 in RA (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415502, which also lists 2 linked publications.
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 4 Jun 2020.