Rheumatoid ArthritisORIENTNCT02322723
Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA
An observational study of Rheumatoid Arthritis, run by AbbVie.
Trial summary
In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderately to severely active Rheumatoid Arthritis patients
Who may be able to join
- Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
- Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment.
- Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration < 3 years.
- Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1))
- Patient is able to sign written informed consent.
- Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs)
- Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
Who cannot join
- Patient with known hypersensitivity to Adalimumab, or any of its components.
- Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab.
- Patient had previous non-response to an anti-TNF agent.
- Patients currently treated with other biologic therapy.
About this study
In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population. This study will collect the required data in real life settings.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Adalimumab, real life, RA, Humira, Rheumatoid Arthritis, effectiveness
- 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 |
|---|---|---|
| Moderately to severely active RA patients | Moderately to severely active RA patients aged 18 years or older, both male and female |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who reached clinical response at 6 months
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
Measured: At 6 months
Secondary outcomes (4)
Proportion of patients who reached clinical response at 24 months
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
Measured: At 24 months
Change in patient's functional status
Proportion of patients reaching HAQ <= 0.5
Measured: Up to 24 months
Change in frequency of sick leave episodes
Change in frequency of sick leave episodes
Measured: Up to 24 months
Change in frequency of outpatient clinic visits
Change in frequency of outpatient clinic visits
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Why it stopped: No enrollment
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 AbbVieThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dina Meyuhas, PhD, Study chair, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322723
- Sponsor's protocol ID
- P13-987
- Acronym
- ORIENT
- Status last verified
- Feb 2016
- First submitted
- 19 Dec 2014
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA
- ClinicalTrials.gov ID
- NCT02322723
- Acronym / sponsor ID
- ORIENT / P13-987
- Conditions
- Rheumatoid Arthritis
- Keywords
- Adalimumab, real life, RA, Humira, Rheumatoid Arthritis, effectiveness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 23 Dec 2014 (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.
In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population. This study will collect the required data in real life settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderately to severely active RA patients | – | –Moderately to severely active RA patients aged 18 years or older, both male and female |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderately to severely active Rheumatoid Arthritis patients
Key inclusion criteria (7 listed)
- Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
- Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment.
- Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration < 3 years.
- Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1))
- Patient is able to sign written informed consent.
Key exclusion criteria (4 listed)
- Patient with known hypersensitivity to Adalimumab, or any of its components.
- Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab.
- Patient had previous non-response to an anti-TNF agent.
- Patients currently treated with other biologic therapy.
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
Proportion of patients who reached clinical response at 6 months
Time frame: At 6 months
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
4 secondary outcomes
Proportion of patients who reached clinical response at 24 months
Time frame: At 24 months
Change in patient's functional status
Time frame: Up to 24 months
Change in frequency of sick leave episodes
Time frame: Up to 24 months
Change in frequency of outpatient clinic visits
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Related InfoLink provided by the sponsor.
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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.
Dina Meyuhas, PhD study chair
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie.
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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Feb 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients who reached clinical response at 6 months (time frame: At 6 months). 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 Feb 2016.