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| Name | Class |
|---|---|
| DataClin | INDUSTRY |
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A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis. (CLEAR)
CLEAR is a phase IV, multi-centric, prospective, observational study to assess the clinical efficacy and safety of Leflunomide as first-line therapy and as add-on therapy to other DMARDs (such as Methotrexate, Hydroxychloroquine, Sulfasalazine) with or without Steroids use in Egyptian patients with Active Rheumatoid Arthritis.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6. | Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients in remission (i.e. CDAI score 0.0 - 2.8), of low disease activity (i.e. CDAI score 2.9 - 10.0), of moderate disease activity (i.e. CDAI score 10.1 - 22.0) and of high disease activity (i.e. CDAI score 22.1 - 76.0) in visits 1 (at baseline) and 6 (at week 36)]. CDAI score: The sum of Tender joint score, Swollen joint score, Patient global score, and Patient global score. CDAI score interpretation: 0.0 - 2.8: Remission 2.9 - 10.0: Low Activity 10.1 - 22.0: Moderate Activity 22.1 - 76.0: High Activity | 9 months |
| Number of Patients With Different Disability Scores in Terms of the Mean Relative Change in Health Assessment Questionnaire - Disability Index Score on Visits 1 and 6. | Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients with mild difficulties to moderate disability, moderate to severe disability and severe to very severe disability; according to the mean relative change in health assessment questionnaire - disability index score (HAQ-DI) at visits 1 (at baseline) and 6 (at week 36)]. A HAQ-DI score of 0.0 - 1 indicates mild difficulties to moderate disability, a HAQ-DI score of 1.1 - 2 indicates moderate to severe disability and a HAQ-DI score of 2.1 - 3 indicates severe to very severe disability. There are eight categories; first score within each category: Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Total score is the mean of the eight category scores. Higher scores indicate greater disability. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs)/ Serious Adverse Events (SAEs) Experienced by Rheumatoid Arthritis Patients Receiving Leflunomide as First-line Therapy and as add-on Therapy to Other DMARD, With or Without Steroids and Their Relation to Study Medication. | Identifying the safety profile of leflunomide whether used as first-line therapy and/or as add-on therapy to other DMARDs with or without steroids in Egyptian patients with active rheumatoid arthritis. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are between 18 and 60 years of age, with Active Rheumatoid Arthritis selected according to the ACR/EULAR classification criteria with score ≥ 6 points.
Patients are Leflunomide naïve or with previous Leflunomide administration (after at least 6-month wash out period from date of baseline visit).
Patients are with or without other DMARDs including Methotrexate, Sulfasalazine and/or Hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance.
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| Name | Affiliation | Role |
|---|---|---|
| Adel Elsayed, MD | Professor, Department of Internal Medicine, Rheumatology and Immunology, Ain Shams University; Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private clinics | Cairo | 1152 | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Row population (n=365) differs from the overall population (n=366) due to missing data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6. | Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients in remission (i.e. CDAI score 0.0 - 2.8), of low disease activity (i.e. CDAI score 2.9 - 10.0), of moderate disease activity (i.e. CDAI score 10.1 - 22.0) and of high disease activity (i.e. CDAI score 22.1 - 76.0) in visits 1 (at baseline) and 6 (at week 36)]. CDAI score: The sum of Tender joint score, Swollen joint score, Patient global score, and Patient global score. CDAI score interpretation: 0.0 - 2.8: Remission 2.9 - 10.0: Low Activity 10.1 - 22.0: Moderate Activity 22.1 - 76.0: High Activity | Only patients with at least one treatment dose and post-assessment score of last observation carried forward (LOCF) convention were analyzed in terms of efficacy endpoints. | Posted | Count of Participants | Participants | 9 months |
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Adverse event data were collected between visit 2 (at week 6) and visit 6 (at week 36); making the time frame of collecting safety data 30 weeks.
An adverse event was defined as any untoward medical occurrence in a clinical investigation subject associated with the use of a product or a medical device; the event does not necessarily need to have a causal relationship with the treatment or usage. A serious adverse event was defined as that from clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic Enzyme increase | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Writer | DataClin | (+2) 01001566602 | mariam.abdalla@dataclin.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2017 | May 5, 2020 | Prot_SAP_000.pdf |
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| 9 months |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Patient's distribution per governorates | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Residence | Count of Participants | Participants |
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| Birth Control | Count of Participants | Participants |
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| Specification of birth control method used | The number analyzed (n=135) is that of patients who were using a birth control method during the study period. | Count of Participants | Participants |
|
| Patients currently taking medications for comorbidities | Count of Participants | Participants |
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| Medications for reasons other than Rheumatoid Arthritis | Count of Participants | Participants |
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| Age at first menstrual period | The row population (n=244) differs from that of the overall female population (n=309) because the data of 65 female patients were missing. | Median | Inter-Quartile Range | years |
|
| Menstruation status | The eligible population for this analysis is the female population (n=309). | Count of Participants | Participants |
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| Regularity of menstrual periods if menstruating or premenopausal | The regularity of menstrual periods in menstruating patients (n=192) and premenopausal patients (n=8). | The row population (n=200) is the sum of patients who were menstruating (n=192) and those who were premenopausal (n=8). | Count of Participants | Participants |
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| Duration of Rheumatoid Arthritis | The row population (n=358) differs from the overall population (n=366) because the data of 8 patients is missing. | Median | Inter-Quartile Range | years |
|
| Did the patient receive leflunomide before? | Count of Participants | Participants |
|
| Did the patient take a loading dose of leflunomide before? | The row population (n=51) differs from the overall population (n=366) because the analysis is concerned with patients who have previously received leflunomide during their past treatment of rheumatoid arthritis. | Count of Participants | Participants |
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| Duration of RA treatment with medications other than leflunomide | Duration of treatment of rheumatoid arthritis (RA) with medications other than leflunomide until the time of the first study visit. | Median | Inter-Quartile Range | months |
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| AEs/SAEs during previous treatment of RA | Count of Participants | Participants |
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| X-ray performed for both hands? | Count of Participants | Participants |
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| Poor prognostic factors | High disease activity was determined as a measure of composite indices (DAS28, SDAI and/or CDAI). | Count of Participants | Participants |
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| Weight | The row population (n=348) is different from the overall population (n=366) given that data on weight is missing from 18 patients. | Mean | Standard Deviation | Kilogram (Kg) |
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| Height | The number analyzed in row (n=346) differs from the overall population (n=366) because height data is missing from 20 patients. | Mean | Standard Deviation | Centimeter (cm) |
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| Heart rate | The row population (n=364) differs from the overall population (n=366) because data on heart rate was missing from 2 patients. | Mean | Standard Deviation | beats/minute |
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| Temperature | The row population (n=359) differs from that of the overall population (n=366) because the temperature data of 7 patients were missing. | Mean | Standard Deviation | Degrees Celsius |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure | Data on diastolic blood pressure is missing from 1 patient. | Mean | Standard Deviation | mmHg |
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| Physical Examination outcome | The row population (n=359) differs from the overall population (n=366) because data on physical examination outcome is missing from 7 patients. | Count of Participants | Participants |
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| Smoking status | The row population (n=364) is different than that of the overall population (n=366) because data on the smoking status of 2 patients is missing. | Count of Participants | Participants |
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| Status of alcohol consumption | The row population (n=363) differs from the overall population (n=366) because data on the status of alcohol consumption is missing from 3 patients. | Count of Participants | Participants |
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| Patients with comorbidities | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
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| OG000 | Single Arm | Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months. |
|
|
| Primary | Number of Patients With Different Disability Scores in Terms of the Mean Relative Change in Health Assessment Questionnaire - Disability Index Score on Visits 1 and 6. | Assessing the clinical efficacy of leflunomide as first-line therapy and as add-on therapy to other DMARDs, with or without steroids in Egyptian patients with active rheumatoid arthritis [in terms of the number of patients with mild difficulties to moderate disability, moderate to severe disability and severe to very severe disability; according to the mean relative change in health assessment questionnaire - disability index score (HAQ-DI) at visits 1 (at baseline) and 6 (at week 36)]. A HAQ-DI score of 0.0 - 1 indicates mild difficulties to moderate disability, a HAQ-DI score of 1.1 - 2 indicates moderate to severe disability and a HAQ-DI score of 2.1 - 3 indicates severe to very severe disability. There are eight categories; first score within each category: Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Total score is the mean of the eight category scores. Higher scores indicate greater disability. | Posted | Count of Participants | Participants | 9 months |
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|
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| Secondary | Number of Adverse Events (AEs)/ Serious Adverse Events (SAEs) Experienced by Rheumatoid Arthritis Patients Receiving Leflunomide as First-line Therapy and as add-on Therapy to Other DMARD, With or Without Steroids and Their Relation to Study Medication. | Identifying the safety profile of leflunomide whether used as first-line therapy and/or as add-on therapy to other DMARDs with or without steroids in Egyptian patients with active rheumatoid arthritis. | In the safety population (n = 398), 23 adverse events were experienced. These are listed in the table. | Posted | Count of Participants | Participants | 9 months |
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| 0 |
| 398 |
| 0 |
| 398 |
| 20 |
| 398 |
| Swollen/Tender joint count increased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| White blood cell count decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| Abdominal discomfort | General disorders | Systematic Assessment |
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| Cardiac death | Cardiac disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bicytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Flushing/hyperhidrosis/dry mouth/lip discoloration | General disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Oropharyngeal pain | General disorders | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rheumatoid Arthritis | Immune system disorders | Systematic Assessment |
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| Scleritis | Eye disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| HAQ score 1.1 - 2 : Visit 6 |
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| HAQ score 2.1 - 3 : Visit 1 |
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| HAQ score 2.1 - 3 : Visit 6 |
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| Title | Measurements |
|---|---|
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| Abdominal discomfort |
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| Cardiac death |
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| Anemia |
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| Bicytopenia |
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| Flushing/hyperhidrosis/dry mouth/lip disoloration |
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| Hypertension |
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| Oropharyngeal pain |
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| Purpura |
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| Rheumatoid arthritis |
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| Scleritis |
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| Supraventricular tachycardia |
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| Diarrhea |
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