Active Rheumatoid Arthritis
Conditions
Keywords
RA
Brief summary
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)
Detailed description
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.
Interventions
None listed
Sponsors
DataClin
Eva Pharma
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Active Rheumatoid Arthritis patients selected according to the ACR/EULAR classification 2010 criteria with score ≥ 6 points. 2. Male or female patients aged 18-60 years old. 3. Leflunomide naïve patients or patients with previous Leflunomide administration (after at least 6 month wash out period from date of baseline visit) who will be prescribed Leflunomide at the sole decision of the treating physician. 4. Patients with or without another DMARDs including Methotrexate, Sulfasalazine and/or Hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance. 5. Patients read, understand and signed informed consent prior to inclusion. 6. Patients willing to complete and literate in the language of the available Health Assessment Questionnaire (HAQ Disability Index) either alone or with minimal assistance from caregivers and/or trained site personnel.
Exclusion criteria
1. Female patients who are pregnant or lactating at the time of inclusion or those who are planning for pregnancy within the coming year from the time of inclusion to the study. 2. Patients with contraindications to active constituent of Leflunomide. 3. Patients with severe concurrent infection (necessitating IV antibiotics or hospitalization). 4. Patients with history of non-treated hepatitis B &/or C infection. 5. Patients with history of severe liver disease (child C class). 6. Patients with history of severe renal insufficiency (creatinine clearance ≤30 ml/min.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6. | 9 months | 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 |
| 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. | 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 9 months | 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 366 |
| Total | 366 |
Baseline characteristics
| Characteristic | Single Arm | — |
|---|---|---|
| AEs/SAEs during previous treatment of RA Missing | 20 Participants | — |
| AEs/SAEs during previous treatment of RA No | 252 Participants | — |
| AEs/SAEs during previous treatment of RA Yes | 94 Participants | — |
| Age at first menstrual period | 13 years | — |
| Age, Continuous | 44.1 years | — |
| Birth Control Missing | 80 Participants | — |
| Birth Control No | 151 Participants | — |
| Birth Control Yes | 135 Participants | — |
| Comorbidities Atherosclerosis | 1 Participants | — |
| Comorbidities Autoimmune disease | 10 Participants | — |
| Comorbidities Coronary artery disease | 3 Participants | — |
| Comorbidities Diabetes Mellitus II | 21 Participants | — |
| Comorbidities Dyslipidemia | 10 Participants | — |
| Comorbidities GIT disorders | 10 Participants | — |
| Comorbidities Hepatobiliary disorders | 1 Participants | — |
| Comorbidities Hypertension | 60 Participants | — |
| Comorbidities Musculoskeletal disoders | 28 Participants | — |
| Comorbidities Myocardial infarction | 1 Participants | — |
| Comorbidities Nervous system disorders | 5 Participants | — |
| Comorbidities Obesity | 32 Participants | — |
| Comorbidities Other | 15 Participants | — |
| Comorbidities Peripheral Vascular Disease | 1 Participants | — |
| Comorbidities Psychiatric disorders | 1 Participants | — |
| Comorbidities Reproductive system disorders | 2 Participants | — |
| Comorbidities Respiratory and thoracic disorders | 6 Participants | — |
| Comorbidities Stroke | 1 Participants | — |
| Diastolic blood pressure | 78.36 mmHg STANDARD_DEVIATION 7.89 | — |
| Did the patient receive leflunomide before? No | 315 Participants | — |
| Did the patient receive leflunomide before? Yes | 51 Participants | — |
| Did the patient take a loading dose of leflunomide before? No | 20 Participants | — |
| Did the patient take a loading dose of leflunomide before? Yes | 31 Participants | — |
| Duration of RA treatment with medications other than leflunomide | 27.7 months | — |
| Duration of Rheumatoid Arthritis | 2.03 years | — |
| Education Basic/primary | 80 Participants | — |
| Education Illiterate | 31 Participants | — |
| Education Secondary | 120 Participants | — |
| Education University/Higher | 135 Participants | — |
| Heart rate | 81.7 beats/minute STANDARD_DEVIATION 8.3 | — |
| Height | 164 Centimeter (cm) STANDARD_DEVIATION 12.19 | — |
| Marital status Divorced | 3 Participants | — |
| Marital status Married | 312 Participants | — |
| Marital status Single | 31 Participants | — |
| Marital status Widow/widower | 20 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Atorvastatin | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Bisporolol | 27 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Calcium | 8 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Calcium carbonate | 5 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Captopril | 5 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Chondroitin sulphate | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Chymotrypsin | 7 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Diclofenac | 14 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Diclofenac sodium | 5 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Enalapril maleate | 8 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Ergocalciferol | 8 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Folic acid | 12 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Glimepiride | 6 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Glucosamine | 9 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Hydrochlorothiazide | 16 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Hydroxychloroquine sulphate | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Ibuprofen | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Levothyroxine | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Magnesium | 6 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Meloxicam | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Metformin | 10 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Methotrexate | 19 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Omeprazole | 17 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Pantoprazole | 9 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Piroxicam | 9 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Prednisolone | 11 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Pregabalin | 5 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Ranitidine | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Silymarin | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Trypsin | 7 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Vitamin B12 | 4 Participants | — |
| Medications for reasons other than Rheumatoid Arthritis Vitamin D | 5 Participants | — |
| Menstruation status Menopausal | 38 Participants | — |
| Menstruation status Menstruating | 192 Participants | — |
| Menstruation status Missing | 1 Participants | — |
| Menstruation status Post-menopausal | 70 Participants | — |
| Menstruation status Premenopausal | 8 Participants | — |
| Patients currently taking medications for comorbidities No | 265 Participants | — |
| Patients currently taking medications for comorbidities Yes | 101 Participants | — |
| Patient's distribution per governorates Alexandria | 108 Participants | — |
| Patient's distribution per governorates Assuit | 3 Participants | — |
| Patient's distribution per governorates Banha | 18 Participants | — |
| Patient's distribution per governorates Cairo | 98 Participants | — |
| Patient's distribution per governorates Ismailia | 32 Participants | — |
| Patient's distribution per governorates Mansoura | 15 Participants | — |
| Patient's distribution per governorates Menoufia | 27 Participants | — |
| Patient's distribution per governorates Minya | 17 Participants | — |
| Patient's distribution per governorates Zagazig | 48 Participants | — |
| Patients with comorbidities No | 251 Participants | — |
| Patients with comorbidities Yes | 115 Participants | — |
| Physical Examination outcome Abnormal | 47 Participants | — |
| Physical Examination outcome Normal | 312 Participants | — |
| Poor prognostic factors Bony erosions by radiograph | 90 Participants | — |
| Poor prognostic factors Extra-articular disease | 19 Participants | — |
| Poor prognostic factors Functional limitation (HAQ) | 240 Participants | — |
| Poor prognostic factors High CRP and ESR or high RF and/or anti-CCP | 237 Participants | — |
| Poor prognostic factors High disease activity | 295 Participants | — |
| Poor prognostic factors High swollen joint count | 136 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Regularity of menstrual periods if menstruating or premenopausal Irregular | 161 Participants | — |
| Regularity of menstrual periods if menstruating or premenopausal Missing | 16 Participants | — |
| Regularity of menstrual periods if menstruating or premenopausal Regular | 23 Participants | — |
| Residence Rural | 138 Participants | — |
| Residence Urban | 228 Participants | — |
| Sex: Female, Male Female | 309 Participants | — |
| Sex: Female, Male Male | 57 Participants | — |
| Smoking status Current | 22 Participants | — |
| Smoking status Former | 9 Participants | — |
| Smoking status Never | 333 Participants | — |
| Specification of birth control method used Barrier methods | 3 Participants | — |
| Specification of birth control method used Hormonal | 43 Participants | — |
| Specification of birth control method used Intrauterine Device (IUD) | 85 Participants | — |
| Specification of birth control method used Natural methods | 3 Participants | — |
| Specification of birth control method used Unspecified | 1 Participants | — |
| Status of alcohol consumption Missing | 3 Participants | — |
| Status of alcohol consumption Never | 363 Participants | — |
| Status of alcohol consumption Yes | 0 Participants | — |
| Systolic blood pressure | 121.9 mmHg STANDARD_DEVIATION 13.66 | — |
| Temperature | 37.2 Degrees Celsius STANDARD_DEVIATION 2.7 | — |
| Weight | 81.3 Kilogram (Kg) STANDARD_DEVIATION 15.25 | — |
| X-ray performed for both hands? Missing | 24 Participants | — |
| X-ray performed for both hands? No | 198 Participants | — |
| X-ray performed for both hands? Yes | 144 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 398 |
| other Total, other adverse events | 20 / 398 |
| serious Total, serious adverse events | 0 / 398 |
Outcome results
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.
Time frame: 9 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
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
Time frame: 9 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
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.
Time frame: 9 months
Population: In the safety population (n = 398), 23 adverse events were experienced. These are listed in the table.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 |
| Single Arm | 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 | 1 Participants |
| Single Arm | 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 | 1 Participants |
| Single Arm | 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 | 1 Participants |
| Single Arm | 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 | 1 Participants |