External Causes of Morbidity and MortalityMTXNCT02641977
Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate
An observational study of External Causes of Morbidity and Mortality, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- External Causes of Morbidity and Mortality
- How many people
- 271 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with rheumatoid arthritis
Who may be able to join
- rheumatoid arthritis
- treatment with methotrexate
- active disease
Who cannot join
- low disease activity
- previous treatment with methotrexate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Internistische und rheumatologische Praxis Gladbeck
Gladbeck, 45964
About this study
Official title: Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte
Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.
Read the detailed description
Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.
Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Causes of Morbidity and MortalityStudies of the same condition, open and under way.
- 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
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietmar Krause, MD, Ruhr University of Bochum
- Investigators
- Dietmar MJ Krause, MD, Principal investigator, University Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641977
- Sponsor's protocol ID
- 19802015
- Acronym
- MTX
- Status last verified
- Oct 2018
- First submitted
- 6 Dec 2015
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte
- ClinicalTrials.gov ID
- NCT02641977
- Acronym / sponsor ID
- MTX / 19802015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Dec 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.
Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.
Detailed description
Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.
Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with rheumatoid arthritis
Key inclusion criteria (3 listed)
- rheumatoid arthritis
- treatment with methotrexate
- active disease
Key exclusion criteria (2 listed)
- low disease activity
- previous treatment with methotrexate
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
mortality
Time frame: 30 years
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 19 Oct 2018.
- Individual participant dataSharing planned: No
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.
Dietmar MJ Krause, MD principal investigator
University Bochum, Germany
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 External Causes of Morbidity and Mortality, run by Ruhr University of Bochum at 1 site in Germany.
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 2 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 19 Oct 2018. 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 Germany. 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?
mortality (time frame: 30 years). 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 19 Oct 2018.