Rheumatoid ArthritisNCT02008266
Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche.
Trial summary
This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 532 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Rheumatoid Arthritis that has been progressing for > 3 months and < 2 years.
Who may be able to join
- Rheumatoid arthritis progressing for < 2 years.
Who cannot join
- Rheumatoid arthritis progressing for < 3 months.
- Rheumatoid arthritis onset at < 18 years of age.
- Participation in another clinical study.
- Rheumatoid arthritis related connective tissue disorder.
- Any neuropsychological disorders.
About this study
Official title: Case Study of the Treatment of Early Rheumatoid Arthritis in Algerian Patients in Both the Private and Public Healthcare Sectors.
This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.
- 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 |
|---|---|---|
| Patients with Rheumatoid Arthritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.
Measured: Single observational visit [Day 1]
Secondary outcomes (3)
Measure disease activity using DAS 28 assessment.
Measured: Single observational visit [Day 1]
Assess joint damage using the modified SHARP method.
Measured: Single observational visit [Day 1]
Assess functional status of patients using the Health Assessment Questionnaire (HAQ).
Measured: Single observational visit [Day 1]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
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 Hoffmann-La RocheThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008266
- Sponsor's protocol ID
- ML25384
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Study of the Treatment of Early Rheumatoid Arthritis in Algerian Patients in Both the Private and Public Healthcare Sectors.
- ClinicalTrials.gov ID
- NCT02008266
- Acronym / sponsor ID
- ML25384
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Dec 2013 (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.
This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Rheumatoid Arthritis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatoid Arthritis that has been progressing for > 3 months and < 2 years.
Key inclusion criteria (1 listed)
- Rheumatoid arthritis progressing for < 2 years.
Key exclusion criteria (5 listed)
- Rheumatoid arthritis progressing for < 3 months.
- Rheumatoid arthritis onset at < 18 years of age.
- Participation in another clinical study.
- Rheumatoid arthritis related connective tissue disorder.
- Any neuropsychological disorders.
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
Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.
Time frame: Single observational visit [Day 1]
3 secondary outcomes
Measure disease activity using DAS 28 assessment.
Time frame: Single observational visit [Day 1]
Assess joint damage using the modified SHARP method.
Time frame: Single observational visit [Day 1]
Assess functional status of patients using the Health Assessment Questionnaire (HAQ).
Time frame: Single observational visit [Day 1]
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 11 Dec 2013.
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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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche.
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 5 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 11 Dec 2013. 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?
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?
Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression. (time frame: Single observational visit [Day 1]). 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 11 Dec 2013.