Rheumatoid ArthritisNCT03316027
Adherence Rate to DMARDS in Egyptian Patients With RA
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
The study aims at determining adherence rate to DMARDS and predicting factors affecting treatment adherence among sample of Egyptian patients with RA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Dec 2019
- 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
- Adult, Older adult
Study population: patients from both sex, aged more than or equal 18 years old, attending Physical Medicine, Rheumatology and Rehabilitation department, Assiut University Hospital, on current diagnosis of RA from at least 6 months and current treatment with one or more of DMARDS, with cognitive level enabling them to interact in the study, and free from psychiatric diagnosis other than effective disorder, associated disability due to neurological disorder or trauma and also free from major internal organ failure.
Who may be able to join
- Age more than or equal 18 years old.
- On current diagnosis of RA determined by a Rheumatologist according to 2010 ACR/EULAR classification criteria for RA.
- On current treatment with one or more of DMARDS from at least 6 months duration.
- Patients with cognitive level enabling them to interact in the study. -
Who cannot join
- Age less than 18 years old.
- Patients receiving one or more of DMARDS of period less than 6 months.
- Patients with psychiatric diagnosis other than effective disorder.
- Patients with associated disability due to neurological disorder or trauma.
- Patients with major internal organ failure e.g. heart failure, end stage renal disease or hepatic failure.
- Patients with severe cognitive impairment interfering with the proper communication and interaction within the study process.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adherence Rate to Disease Modifying Anti Rheumatic Drugs in Egyptian Patients With Rheumatoid Arthritis: Possible Predictions and Correlations
The study aims at determining adherence rate to DMARDS and predicting factors affecting treatment adherence among sample of Egyptian patients with RA.
Read the detailed description
Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation of the joints. It is chronic disease and often progressive in course and has a strong impact on people's everyday lives.
Disease Modifying Anti-Rheumatic Drugs (DMARDS), such as methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine are the cornerstone of therapy in RA and are invariably used as initial therapy.
These drugs have shown to retard disease progression including joint destruction.
It is believed that adherence to treatment is crucial for successful therapy, however, non-adherence is a substantial problem in patients with chronic rheumatic conditions, including RA.
Previous studies have reported that DMARDS non adherence results in more disease activity, loss of function, and a lower quality of life.
The depression is a common co-morbidity in RA, its presence can alter the course of RA negatively via cognitive-behavioral or inflammatory pathways: patients with concurrent depression suffer from more pain, show a heightened disease activity.
As non-adherence to medication regimen is considered a serious public health issue that can have great impact on clinical and economic consequences. therefore, it is crucial for health care providers to assess the patient condition, predict the possible causes of non-adherence, and put a policy for increasing medication adherence and achieving the best health outcome.
Also, improving medication adherence enhances patients' safety and health condition.
- 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.
Percentage of patients adherent to the treatment through MMAS-8.
The use of Morisky Medication Adherence Scale 8- item (MMAS-8) to determining percentage of patients adherent to treatment.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startNov 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Moustafa Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316027
- Sponsor's protocol ID
- DMARDS in RA
- Status last verified
- Jul 2019
- First submitted
- 30 Sep 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harrold LR, Andrade SE. Medication adherence of patients with selected rheumatic conditions: a systematic review of the literature. Semin Arthritis Rheum. 2009 Apr;38(5):396-402. doi: 10.1016/j.semarthrit.2008.01.011. Epub 2008 Mar 12.
PubMed 18336875Contreras-Yanez I, Ponce De Leon S, Cabiedes J, Rull-Gabayet M, Pascual-Ramos V. Inadequate therapy behavior is associated to disease flares in patients with rheumatoid arthritis who have achieved remission with disease-modifying antirheumatic drugs. Am J Med Sci. 2010 Oct;340(4):282-90. doi: 10.1097/MAJ.0b013e3181e8bcb0.
PubMed 20881757Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
PubMed 18490431Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.
PubMed 12508408Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Rate to Disease Modifying Anti Rheumatic Drugs in Egyptian Patients With Rheumatoid Arthritis: Possible Predictions and Correlations
- ClinicalTrials.gov ID
- NCT03316027
- Acronym / sponsor ID
- DMARDS in RA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Oct 2017 (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 study aims at determining adherence rate to DMARDS and predicting factors affecting treatment adherence among sample of Egyptian patients with RA.
Detailed description
Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation of the joints. It is chronic disease and often progressive in course and has a strong impact on people's everyday lives.
Disease Modifying Anti-Rheumatic Drugs (DMARDS), such as methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine are the cornerstone of therapy in RA and are invariably used as initial therapy.
These drugs have shown to retard disease progression including joint destruction.
It is believed that adherence to treatment is crucial for successful therapy, however, non-adherence is a substantial problem in patients with chronic rheumatic conditions, including RA.
Previous studies have reported that DMARDS non adherence results in more disease activity, loss of function, and a lower quality of life.
The depression is a common co-morbidity in RA, its presence can alter the course of RA negatively via cognitive-behavioral or inflammatory pathways: patients with concurrent depression suffer from more pain, show a heightened disease activity.
As non-adherence to medication regimen is considered a serious public health issue that can have great impact on clinical and economic consequences. therefore, it is crucial for health care providers to assess the patient condition, predict the possible causes of non-adherence, and put a policy for increasing medication adherence and achieving the best health outcome.
Also, improving medication adherence enhances patients' safety and health condition.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients from both sex, aged more than or equal 18 years old, attending Physical Medicine, Rheumatology and Rehabilitation department, Assiut University Hospital, on current diagnosis of RA from at least 6 months and current treatment with one or more of DMARDS, with cognitive level enabling them to interact in the study, and free from psychiatric diagnosis other than effective disorder, associated disability due to neurological disorder or trauma and also free from major internal organ failure.
Key inclusion criteria (4 listed)
- Age more than or equal 18 years old.
- On current diagnosis of RA determined by a Rheumatologist according to 2010 ACR/EULAR classification criteria for RA.
- On current treatment with one or more of DMARDS from at least 6 months duration.
- Patients with cognitive level enabling them to interact in the study. -
Key exclusion criteria (6 listed)
- Age less than 18 years old.
- Patients receiving one or more of DMARDS of period less than 6 months.
- Patients with psychiatric diagnosis other than effective disorder.
- Patients with associated disability due to neurological disorder or trauma.
- Patients with major internal organ failure e.g. heart failure, end stage renal disease or hepatic failure.
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
Percentage of patients adherent to the treatment through MMAS-8.
Time frame: 6 months.
The use of Morisky Medication Adherence Scale 8- item (MMAS-8) to determining percentage of patients adherent to treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 18336875Harrold LR, Andrade SE. Medication adherence of patients with selected rheumatic conditions: a systematic review of the literature. Semin Arthritis Rheum. 2009 Apr;38(5):396-402. doi: 10.1016/j.semarthrit.2008.01.011. Epub 2008 Mar 12.
- Background: PubMed 20881757Contreras-Yanez I, Ponce De Leon S, Cabiedes J, Rull-Gabayet M, Pascual-Ramos V. Inadequate therapy behavior is associated to disease flares in patients with rheumatoid arthritis who have achieved remission with disease-modifying antirheumatic drugs. Am J Med Sci. 2010 Oct;340(4):282-90. doi: 10.1097/MAJ.0b013e3181e8bcb0.
- Background: PubMed 18490431Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
- Background: PubMed 12508408Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 2003 Jan;30(1):167-78.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
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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 4 inclusion and 6 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 5 Jul 2019. 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 Esraa Moustafa Mohammed, Master student (01094335622, moustafaesraa0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients adherent to the treatment through MMAS-8. (time frame: 6 months.). 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 NCT03316027, which also lists 5 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 5 Jul 2019.