Rheumatoid ArthritisCATCH-USNCT02386527
Consortium of Early Arthritis Cohorts USA
An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to Apr 2024
- How long will I take part?
- 3 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Most patients will have been referred by their primary care providers (PCP) for an expedited assessment and all will have met inclusion criteria. If the patient is appropriate for inclusion into the cohort, the study will be explained to the patient by the rheumatologist or designate. If he/she is interested, the information sheet and consent form will be reviewed with the study nurse or coordinator and consent will be obtained. As this is a study of usual care, study data is the information collected during regular clinic visits. Therefore, the patient will be consenting to have the data from their regular assessments entered into the study database. A schedule of regular visits has been identified in advance in keeping with best clinical practice and management of ERA.
Who may be able to join
- Patient was 18 years of age or over at time of referral
- Joint symptoms for < 12 months
- 2+ swollen joints OR 1 swollen joint with one of the following: Rheumatoid Factor > 20 IU, (+) anti-CCP antibody, morning stiffness > 45 minutes, responded to NSAIDs, (+) MTP squeeze test
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Consortium of Early Arthritis Cohorts USA - A Prospective Cohort Study of Adults With New Consent Inflammatory Arthritis Symptoms to Understand Predictors of Optimal Outcomes
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients.
The goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. Research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the RA patient. This also requires that a diagnosis of RA be made as early on as possible, and herein lies the challenge, i.e. identifying the RA patient early on in the course of their disease.
Read the detailed description
This is a study of usual care, a prospective cohort of all eligible and consenting patients referred to the Inflammatory Arthritis Center of Excellence and the Division of Rheumatology, Department of Medicine at HSS as well as 3 consortium sites across the U.S.
In order to study the effectiveness of recommended treatments in usual practice in different patients for short-term and long-term outcomes, and to determine factors that may predict how a patient's disease might progress over time, investigators will need to analyze and describe the strategies used to manage these patients and will need to understand:
- The frequency of single time-point and sustained (two or more time points) remission or low disease activity over time ii. Factors that influence remission iii. Which patients can achieve persistent sustained remission, and iv. Who can undergo drug withdrawal and still sustain remission of low disease activity v. Factors associated with treatment optimization or barriers to achieving this
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapidity and sustainability of SDAI remission as achieved over a one year period
Measured: 3 months, 6 months, 9 months and 12 months of follow-up
Secondary outcomes (2)
The proportion of patients achieving DAS28 remission and CDAI remission twice
Measured: 3 months, 6 months, 9 months and 12 months of follow-up
Rapid radiographic progression, as measured by a van der Heijde Sharp Score change of 5 point or more
Measured: 2 months and 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start1 Dec 2014
- Primary completionApr 2024
- Study completionApr 2024
Why it stopped: This study has been terminated by PI and BRANY IRB on 4/18/24.
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 Hospital for Special Surgery, New YorkThe 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
- 119 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Johns Hopkins University
- Responsible party
- Principal investigator, Vivian Bykerk, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386527
- Sponsor's protocol ID
- 2014-229
- Acronym
- CATCH-US
- Status last verified
- Nov 2024
- First submitted
- 26 Feb 2015
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium of Early Arthritis Cohorts USA - A Prospective Cohort Study of Adults With New Consent Inflammatory Arthritis Symptoms to Understand Predictors of Optimal Outcomes
- ClinicalTrials.gov ID
- NCT02386527
- Acronym / sponsor ID
- CATCH-US / 2014-229
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study has been terminated by PI and BRANY IRB on 4/18/24.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Northwestern University, Johns Hopkins University
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- Apr 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 12 Mar 2015 (estimated)
- 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.
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients.
The goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. Research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the RA patient. This also requires that a diagnosis of RA be made as early on as possible, and herein lies the challenge, i.e. identifying the RA patient early on in the course of their disease.
Detailed description
This is a study of usual care, a prospective cohort of all eligible and consenting patients referred to the Inflammatory Arthritis Center of Excellence and the Division of Rheumatology, Department of Medicine at HSS as well as 3 consortium sites across the U.S.
In order to study the effectiveness of recommended treatments in usual practice in different patients for short-term and long-term outcomes, and to determine factors that may predict how a patient's disease might progress over time, investigators will need to analyze and describe the strategies used to manage these patients and will need to understand:
- The frequency of single time-point and sustained (two or more time points) remission or low disease activity over time ii. Factors that influence remission iii. Which patients can achieve persistent sustained remission, and iv. Who can undergo drug withdrawal and still sustain remission of low disease activity v. Factors associated with treatment optimization or barriers to achieving this
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Most patients will have been referred by their primary care providers (PCP) for an expedited assessment and all will have met inclusion criteria. If the patient is appropriate for inclusion into the cohort, the study will be explained to the patient by the rheumatologist or designate. If he/she is interested, the information sheet and consent form will be reviewed with the study nurse or coordinator and consent will be obtained. As this is a study of usual care, study data is the information collected during regular clinic visits. Therefore, the patient will be consenting to have the data from their regular assessments entered into the study database. A schedule of regular visits has been identified in advance in keeping with best clinical practice and management of ERA.
Key inclusion criteria (3 listed)
- Patient was 18 years of age or over at time of referral
- Joint symptoms for < 12 months
- 2+ swollen joints OR 1 swollen joint with one of the following: Rheumatoid Factor > 20 IU, (+) anti-CCP antibody, morning stiffness > 45 minutes, responded to NSAIDs, (+) MTP squeeze test
Key exclusion criteria (0 listed)
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
Rapidity and sustainability of SDAI remission as achieved over a one year period
Time frame: 3 months, 6 months, 9 months and 12 months of follow-up
2 secondary outcomes
The proportion of patients achieving DAS28 remission and CDAI remission twice
Time frame: 3 months, 6 months, 9 months and 12 months of follow-up
Rapid radiographic progression, as measured by a van der Heijde Sharp Score change of 5 point or more
Time frame: 2 months and 24 months of follow-up
Results and safety
The study was stopped early (reason given: This study has been terminated by PI and BRANY IRB on 4/18/24.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hospital for Special Surgery, New York at 1 site in United States.
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 0 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: stopped early, as of the sponsor's last update on 13 Apr 2025. 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 United States. 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 was stopped early (reason given: This study has been terminated by PI and BRANY IRB on 4/18/24.). Results are not available in the source record.
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?
Rapidity and sustainability of SDAI remission as achieved over a one year period (time frame: 3 months, 6 months, 9 months and 12 months of follow-up). 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 Apr 2025.