An observational study in Active Rheumatoid Arthritis, sponsored by Eva Pharma. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-06-30.
Sponsored by Eva Pharma · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 398 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Eva Pharma is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Time frame: 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.
Time frame: 9 months
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.
Time frame: 9 months
| Milestone | Single Arm |
|---|---|
| Started | 398 |
| Completed | 366 |
| Not completed | 32 |
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
| Participants | Single Arm |
|---|---|
| Disease Severity: Remission : Visit 1 | 0 |
| Disease Severity: Remission : Visit 6 | 70 |
| Disease severity: Low activity : Visit 1 | 10 |
| Disease severity: Low activity : Visit 6 | 116 |
| Disease severity: Moderate activity : Visit 1 | 53 |
| Disease severity: Moderate activity : Visit 6 | 113 |
| Disease severity: High activity : Visit 1 | 303 |
| Disease severity: High activity : Visit 6 | 67 |
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.
| Participants | Single Arm |
|---|---|
| HAQ score 0.0 - 1 : Visit 1 | 112 |
| HAQ score 0.0 - 1 : Visit 6 | 318 |
| HAQ score 1.1 - 2 : Visit 1 | 200 |
| HAQ score 1.1 - 2 : Visit 6 | 43 |
| HAQ score 2.1 - 3 : Visit 1 | 54 |
| HAQ score 2.1 - 3 : Visit 6 | 5 |
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.
| Participants | Single Arm |
|---|---|
| Hepatic enzyme increased | 6 |
| Swollen/tender joint count increased | 2 |
| White blood cell count decreased | 2 |
| Abdominal discomfort | 2 |
| Cardiac death | 1 |
| Anemia | 1 |
| Bicytopenia | 1 |
| Flushing/hyperhidrosis/dry mouth/lip disoloration | 1 |
| Hypertension | 1 |
| Oropharyngeal pain | 1 |
| Purpura | 1 |
| Rheumatoid arthritis | 1 |
| Scleritis | 1 |
| Supraventricular tachycardia | 1 |
| Diarrhea | 1 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | 0/398 (0%) | 0/398 (0%) | 20/398 (5%) |
| Event | Single Arm |
|---|---|
| Hepatic Enzyme increaseHepatobiliary disorders | 6/398 |
| Swollen/Tender joint count increasedMusculoskeletal and connective tissue disorders | 2/398 |
| White blood cell count decreasedBlood and lymphatic system disorders | 2/398 |
| Abdominal discomfortGeneral disorders | 2/398 |
| Cardiac deathCardiac disorders | 1/398 |
| AnemiaBlood and lymphatic system disorders | 1/398 |
| BicytopeniaBlood and lymphatic system disorders | 1/398 |
| Flushing/hyperhidrosis/dry mouth/lip discolorationGeneral disorders | 1/398 |
| HypertensionCardiac disorders | 1/398 |
| Oropharyngeal painGeneral disorders | 1/398 |
| Age, Continuous(years) | Single Arm |
|---|---|
| Median | 44.1 (35.78 to 52.42) |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 309 |
| Male | 57 |
| Race and Ethnicity Not Collected(Participants) | Single Arm |
|---|
| Patient's distribution per governorates(Participants) | Single Arm |
|---|---|
| Alexandria | 108 |
| Assuit | 3 |
| Banha | 18 |
| Cairo | 98 |
| Ismailia | 32 |
| Mansoura | 15 |
| Menoufia | 27 |
| Minya | 17 |
| Zagazig | 48 |
| Marital status(Participants) | Single Arm |
|---|---|
| Single | 31 |
| Married | 312 |
| Divorced | 3 |
| Widow/widower | 20 |
| Education(Participants) | Single Arm |
|---|---|
| Illiterate | 31 |
| Basic/primary | 80 |
| Secondary | 120 |
| University/Higher | 135 |
| Residence(Participants) | Single Arm |
|---|---|
| Rural | 138 |
| Urban | 228 |
| Birth Control(Participants) | Single Arm |
|---|---|
| No | 151 |
| Yes | 135 |
| Missing | 80 |
24 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Eva Pharma