Trial Outcomes & Findings for Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis (NCT NCT03599986)
NCT ID: NCT03599986
Last Updated: 2020-06-30
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
398 participants
Primary outcome timeframe
9 months
Results posted on
2020-06-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
398
|
|
Overall Study
COMPLETED
|
366
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row population (n=365) differs from the overall population (n=366) due to missing data.
Baseline characteristics by cohort
| Measure |
Single Arm
n=366 Participants
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.
|
|---|---|
|
Age, Continuous
|
44.1 years
n=365 Participants • Row population (n=365) differs from the overall population (n=366) due to missing data.
|
|
Sex: Female, Male
Female
|
309 Participants
n=366 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Alexandria
|
108 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Assuit
|
3 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Banha
|
18 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Cairo
|
98 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Ismailia
|
32 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Mansoura
|
15 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Menoufia
|
27 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Minya
|
17 Participants
n=366 Participants
|
|
Patient's distribution per governorates
Zagazig
|
48 Participants
n=366 Participants
|
|
Marital status
Single
|
31 Participants
n=366 Participants
|
|
Marital status
Married
|
312 Participants
n=366 Participants
|
|
Marital status
Divorced
|
3 Participants
n=366 Participants
|
|
Marital status
Widow/widower
|
20 Participants
n=366 Participants
|
|
Education
Illiterate
|
31 Participants
n=366 Participants
|
|
Education
Basic/primary
|
80 Participants
n=366 Participants
|
|
Education
Secondary
|
120 Participants
n=366 Participants
|
|
Education
University/Higher
|
135 Participants
n=366 Participants
|
|
Residence
Rural
|
138 Participants
n=366 Participants
|
|
Residence
Urban
|
228 Participants
n=366 Participants
|
|
Birth Control
No
|
151 Participants
n=366 Participants
|
|
Birth Control
Yes
|
135 Participants
n=366 Participants
|
|
Birth Control
Missing
|
80 Participants
n=366 Participants
|
|
Specification of birth control method used
Hormonal
|
43 Participants
n=135 Participants • The number analyzed (n=135) is that of patients who were using a birth control method during the study period.
|
|
Specification of birth control method used
Intrauterine Device (IUD)
|
85 Participants
n=135 Participants • The number analyzed (n=135) is that of patients who were using a birth control method during the study period.
|
|
Specification of birth control method used
Barrier methods
|
3 Participants
n=135 Participants • The number analyzed (n=135) is that of patients who were using a birth control method during the study period.
|
|
Specification of birth control method used
Natural methods
|
3 Participants
n=135 Participants • The number analyzed (n=135) is that of patients who were using a birth control method during the study period.
|
|
Specification of birth control method used
Unspecified
|
1 Participants
n=135 Participants • The number analyzed (n=135) is that of patients who were using a birth control method during the study period.
|
|
Patients currently taking medications for comorbidities
Yes
|
101 Participants
n=366 Participants
|
|
Patients currently taking medications for comorbidities
No
|
265 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Bisporolol
|
27 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Methotrexate
|
19 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Omeprazole
|
17 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Hydrochlorothiazide
|
16 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Diclofenac
|
14 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Folic acid
|
12 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Prednisolone
|
11 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Metformin
|
10 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Glucosamine
|
9 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Pantoprazole
|
9 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Piroxicam
|
9 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Calcium
|
8 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Enalapril maleate
|
8 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Ergocalciferol
|
8 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Chymotrypsin
|
7 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Trypsin
|
7 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Glimepiride
|
6 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Magnesium
|
6 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Calcium carbonate
|
5 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Captopril
|
5 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Diclofenac sodium
|
5 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Pregabalin
|
5 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Vitamin D
|
5 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Atorvastatin
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Chondroitin sulphate
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Hydroxychloroquine sulphate
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Ibuprofen
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Levothyroxine
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Meloxicam
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Ranitidine
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Silymarin
|
4 Participants
n=366 Participants
|
|
Medications for reasons other than Rheumatoid Arthritis
Vitamin B12
|
4 Participants
n=366 Participants
|
|
Age at first menstrual period
|
13 years
n=244 Participants • The row population (n=244) differs from that of the overall female population (n=309) because the data of 65 female patients were missing.
|
|
Menstruation status
Menstruating
|
192 Participants
n=309 Participants • The eligible population for this analysis is the female population (n=309).
|
|
Menstruation status
Premenopausal
|
8 Participants
n=309 Participants • The eligible population for this analysis is the female population (n=309).
|
|
Menstruation status
Menopausal
|
38 Participants
n=309 Participants • The eligible population for this analysis is the female population (n=309).
|
|
Menstruation status
Post-menopausal
|
70 Participants
n=309 Participants • The eligible population for this analysis is the female population (n=309).
|
|
Menstruation status
Missing
|
1 Participants
n=309 Participants • The eligible population for this analysis is the female population (n=309).
|
|
Regularity of menstrual periods if menstruating or premenopausal
Regular
|
23 Participants
n=200 Participants • The row population (n=200) is the sum of patients who were menstruating (n=192) and those who were premenopausal (n=8).
|
|
Regularity of menstrual periods if menstruating or premenopausal
Irregular
|
161 Participants
n=200 Participants • The row population (n=200) is the sum of patients who were menstruating (n=192) and those who were premenopausal (n=8).
|
|
Regularity of menstrual periods if menstruating or premenopausal
Missing
|
16 Participants
n=200 Participants • The row population (n=200) is the sum of patients who were menstruating (n=192) and those who were premenopausal (n=8).
|
|
Duration of Rheumatoid Arthritis
|
2.03 years
n=358 Participants • The row population (n=358) differs from the overall population (n=366) because the data of 8 patients is missing.
|
|
Did the patient receive leflunomide before?
Yes
|
51 Participants
n=366 Participants
|
|
Did the patient receive leflunomide before?
No
|
315 Participants
n=366 Participants
|
|
Did the patient take a loading dose of leflunomide before?
Yes
|
31 Participants
n=51 Participants • 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.
|
|
Did the patient take a loading dose of leflunomide before?
No
|
20 Participants
n=51 Participants • 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.
|
|
Duration of RA treatment with medications other than leflunomide
|
27.7 months
n=366 Participants
|
|
AEs/SAEs during previous treatment of RA
Yes
|
94 Participants
n=366 Participants
|
|
AEs/SAEs during previous treatment of RA
No
|
252 Participants
n=366 Participants
|
|
AEs/SAEs during previous treatment of RA
Missing
|
20 Participants
n=366 Participants
|
|
X-ray performed for both hands?
Yes
|
144 Participants
n=366 Participants
|
|
X-ray performed for both hands?
No
|
198 Participants
n=366 Participants
|
|
X-ray performed for both hands?
Missing
|
24 Participants
n=366 Participants
|
|
Poor prognostic factors
Bony erosions by radiograph
|
90 Participants
n=366 Participants
|
|
Poor prognostic factors
High swollen joint count
|
136 Participants
n=366 Participants
|
|
Poor prognostic factors
Extra-articular disease
|
19 Participants
n=366 Participants
|
|
Poor prognostic factors
Functional limitation (HAQ)
|
240 Participants
n=366 Participants
|
|
Poor prognostic factors
High disease activity
|
295 Participants
n=366 Participants
|
|
Poor prognostic factors
High CRP and ESR or high RF and/or anti-CCP
|
237 Participants
n=366 Participants
|
|
Weight
|
81.3 Kilogram (Kg)
STANDARD_DEVIATION 15.25 • n=348 Participants • The row population (n=348) is different from the overall population (n=366) given that data on weight is missing from 18 patients.
|
|
Height
|
164 Centimeter (cm)
STANDARD_DEVIATION 12.19 • n=346 Participants • The number analyzed in row (n=346) differs from the overall population (n=366) because height data is missing from 20 patients.
|
|
Heart rate
|
81.7 beats/minute
STANDARD_DEVIATION 8.3 • n=364 Participants • The row population (n=364) differs from the overall population (n=366) because data on heart rate was missing from 2 patients.
|
|
Temperature
|
37.2 Degrees Celsius
STANDARD_DEVIATION 2.7 • n=359 Participants • The row population (n=359) differs from that of the overall population (n=366) because the temperature data of 7 patients were missing.
|
|
Systolic blood pressure
|
121.9 mmHg
STANDARD_DEVIATION 13.66 • n=366 Participants
|
|
Diastolic blood pressure
|
78.36 mmHg
STANDARD_DEVIATION 7.89 • n=365 Participants • Data on diastolic blood pressure is missing from 1 patient.
|
|
Physical Examination outcome
Normal
|
312 Participants
n=359 Participants • The row population (n=359) differs from the overall population (n=366) because data on physical examination outcome is missing from 7 patients.
|
|
Physical Examination outcome
Abnormal
|
47 Participants
n=359 Participants • The row population (n=359) differs from the overall population (n=366) because data on physical examination outcome is missing from 7 patients.
|
|
Smoking status
Never
|
333 Participants
n=364 Participants • 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.
|
|
Smoking status
Former
|
9 Participants
n=364 Participants • 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.
|
|
Smoking status
Current
|
22 Participants
n=364 Participants • 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.
|
|
Status of alcohol consumption
Never
|
363 Participants
n=363 Participants • 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.
|
|
Status of alcohol consumption
Yes
|
0 Participants
n=363 Participants • 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.
|
|
Status of alcohol consumption
Missing
|
3 Participants
n=366 Participants • 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.
|
|
Patients with comorbidities
Yes
|
115 Participants
n=366 Participants
|
|
Patients with comorbidities
No
|
251 Participants
n=366 Participants
|
|
Comorbidities
Hypertension
|
60 Participants
n=366 Participants
|
|
Comorbidities
Atherosclerosis
|
1 Participants
n=366 Participants
|
|
Comorbidities
Coronary artery disease
|
3 Participants
n=366 Participants
|
|
Comorbidities
Myocardial infarction
|
1 Participants
n=366 Participants
|
|
Comorbidities
Stroke
|
1 Participants
n=366 Participants
|
|
Comorbidities
Peripheral Vascular Disease
|
1 Participants
n=366 Participants
|
|
Comorbidities
Diabetes Mellitus II
|
21 Participants
n=366 Participants
|
|
Comorbidities
Obesity
|
32 Participants
n=366 Participants
|
|
Comorbidities
Dyslipidemia
|
10 Participants
n=366 Participants
|
|
Comorbidities
Respiratory and thoracic disorders
|
6 Participants
n=366 Participants
|
|
Comorbidities
GIT disorders
|
10 Participants
n=366 Participants
|
|
Comorbidities
Hepatobiliary disorders
|
1 Participants
n=366 Participants
|
|
Comorbidities
Nervous system disorders
|
5 Participants
n=366 Participants
|
|
Comorbidities
Psychiatric disorders
|
1 Participants
n=366 Participants
|
|
Comorbidities
Reproductive system disorders
|
2 Participants
n=366 Participants
|
|
Comorbidities
Musculoskeletal disoders
|
28 Participants
n=366 Participants
|
|
Comorbidities
Autoimmune disease
|
10 Participants
n=366 Participants
|
|
Comorbidities
Other
|
15 Participants
n=366 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 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.
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
Outcome measures
| Measure |
Single Arm
n=366 Participants
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.
|
|---|---|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease Severity: Remission : Visit 1
|
0 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease Severity: Remission : Visit 6
|
70 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: Low activity : Visit 1
|
10 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: Low activity : Visit 6
|
116 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: Moderate activity : Visit 1
|
53 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: Moderate activity : Visit 6
|
113 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: High activity : Visit 1
|
303 Participants
|
|
Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Disease severity: High activity : Visit 6
|
67 Participants
|
PRIMARY outcome
Timeframe: 9 monthsAssessing 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.
Outcome measures
| Measure |
Single Arm
n=366 Participants
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.
|
|---|---|
|
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.
HAQ score 0.0 - 1 : Visit 1
|
112 Participants
|
|
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.
HAQ score 0.0 - 1 : Visit 6
|
318 Participants
|
|
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.
HAQ score 1.1 - 2 : Visit 1
|
200 Participants
|
|
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.
HAQ score 1.1 - 2 : Visit 6
|
43 Participants
|
|
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.
HAQ score 2.1 - 3 : Visit 1
|
54 Participants
|
|
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.
HAQ score 2.1 - 3 : Visit 6
|
5 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: In the safety population (n = 398), 23 adverse events were experienced. These are listed in the table.
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.
Outcome measures
| Measure |
Single Arm
n=398 Participants
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.
|
|---|---|
|
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.
Hepatic enzyme increased
|
6 Participants
|
|
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.
Swollen/tender joint count increased
|
2 Participants
|
|
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.
White blood cell count decreased
|
2 Participants
|
|
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.
Abdominal discomfort
|
2 Participants
|
|
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.
Cardiac death
|
1 Participants
|
|
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.
Anemia
|
1 Participants
|
|
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.
Bicytopenia
|
1 Participants
|
|
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.
Flushing/hyperhidrosis/dry mouth/lip disoloration
|
1 Participants
|
|
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.
Hypertension
|
1 Participants
|
|
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.
Oropharyngeal pain
|
1 Participants
|
|
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.
Purpura
|
1 Participants
|
|
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.
Rheumatoid arthritis
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1 Participants
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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.
Scleritis
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1 Participants
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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.
Supraventricular tachycardia
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1 Participants
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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.
Diarrhea
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1 Participants
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Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
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Single Arm
n=398 participants at risk
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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Hepatobiliary disorders
Hepatic Enzyme increase
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1.5%
6/398 • 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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Musculoskeletal and connective tissue disorders
Swollen/Tender joint count increased
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0.50%
2/398 • 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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Blood and lymphatic system disorders
White blood cell count decreased
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0.50%
2/398 • 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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General disorders
Abdominal discomfort
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0.50%
2/398 • 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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Cardiac disorders
Cardiac death
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0.25%
1/398 • 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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Blood and lymphatic system disorders
Anemia
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0.25%
1/398 • 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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Blood and lymphatic system disorders
Bicytopenia
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0.25%
1/398 • 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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General disorders
Flushing/hyperhidrosis/dry mouth/lip discoloration
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0.25%
1/398 • 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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Cardiac disorders
Hypertension
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0.25%
1/398 • 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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General disorders
Oropharyngeal pain
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0.25%
1/398 • 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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Skin and subcutaneous tissue disorders
Purpura
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0.25%
1/398 • 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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Immune system disorders
Rheumatoid Arthritis
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0.25%
1/398 • 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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Eye disorders
Scleritis
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0.25%
1/398 • 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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Cardiac disorders
Supraventricular tachycardia
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0.25%
1/398 • 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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Gastrointestinal disorders
Diarrhea
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0.25%
1/398 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place