Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis (CLEAR)

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ClinicalTrials.gov Identifier: NCT03599986

Recruitment Status : Completed

First Posted : July 26, 2018

Results First Posted : June 30, 2020

Last Update Posted : June 30, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

DataClin

Information provided by (Responsible Party):

Adel Mahmoud Elsayed, Eva Pharma

Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Prospective
Condition	Active Rheumatoid Arthritis
Enrollment	398

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Single Arm
Arm/Group Description	Adult Egyptian patients with active...
Arm/Group Description	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.
Period Title: Overall Study
Started	398
Completed	366
Not Completed	32

Baseline Characteristics

Arm/Group Title		Single Arm
Arm/Group Description		Adult Egyptian patients with active...
Arm/Group Description		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 Number of Baseline Participants		366
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous ^[1] Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	365 participants
		44.1 (35.78 to 52.42)
		[1] Measure Analysis Population Description: Row population (n=365) differs from the overall population (n=366) due to missing data.
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	366 participants
	Female	309 84.4%
	Male	57 15.6%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Patient's distribution per governorates Measure Type: Count of Participants Unit of measure: Participants
Alexandria	Number Analyzed	366 participants
Alexandria		108 29.5%
Assuit	Number Analyzed	366 participants
Assuit		3 0.8%
Banha	Number Analyzed	366 participants
Banha		18 4.9%
Cairo	Number Analyzed	366 participants
Cairo		98 26.8%
Ismailia	Number Analyzed	366 participants
Ismailia		32 8.7%
Mansoura	Number Analyzed	366 participants
Mansoura		15 4.1%
Menoufia	Number Analyzed	366 participants
Menoufia		27 7.4%
Minya	Number Analyzed	366 participants
Minya		17 4.6%
Zagazig	Number Analyzed	366 participants
Zagazig		48 13.1%
Marital status Measure Type: Count of Participants Unit of measure: Participants
Single	Number Analyzed	366 participants
Single		31 8.5%
Married	Number Analyzed	366 participants
Married		312 85.2%
Divorced	Number Analyzed	366 participants
Divorced		3 0.8%
Widow/widower	Number Analyzed	366 participants
Widow/widower		20 5.5%
Education Measure Type: Count of Participants Unit of measure: Participants
Illiterate	Number Analyzed	366 participants
Illiterate		31 8.5%
Basic/primary	Number Analyzed	366 participants
Basic/primary		80 21.9%
Secondary	Number Analyzed	366 participants
Secondary		120 32.8%
University/Higher	Number Analyzed	366 participants
University/Higher		135 36.9%
Residence Measure Type: Count of Participants Unit of measure: Participants
Rural	Number Analyzed	366 participants
Rural		138 37.7%
Urban	Number Analyzed	366 participants
Urban		228 62.3%
Birth Control Measure Type: Count of Participants Unit of measure: Participants
No	Number Analyzed	366 participants
No		151 41.3%
Yes	Number Analyzed	366 participants
Yes		135 36.9%
Missing	Number Analyzed	366 participants
Missing		80 21.9%
Specification of birth control method used ^[1] Measure Type: Count of Participants Unit of measure: Participants
Hormonal	Number Analyzed	135 participants
Hormonal		43 31.9%
Intrauterine Device (IUD)	Number Analyzed	135 participants
Intrauterine Device (IUD)		85 63.0%
Barrier methods	Number Analyzed	135 participants
Barrier methods		3 2.2%
Natural methods	Number Analyzed	135 participants
Natural methods		3 2.2%
Unspecified	Number Analyzed	135 participants
Unspecified		1 0.7%
		[1] Measure Analysis Population Description: 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 Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	366 participants
Yes		101 27.6%
No	Number Analyzed	366 participants
No		265 72.4%
Medications for reasons other than Rheumatoid Arthritis Measure Type: Count of Participants Unit of measure: Participants
Bisporolol	Number Analyzed	366 participants
Bisporolol		27 7.4%
Methotrexate	Number Analyzed	366 participants
Methotrexate		19 5.2%
Omeprazole	Number Analyzed	366 participants
Omeprazole		17 4.6%
Hydrochlorothiazide	Number Analyzed	366 participants
Hydrochlorothiazide		16 4.4%
Diclofenac	Number Analyzed	366 participants
Diclofenac		14 3.8%
Folic acid	Number Analyzed	366 participants
Folic acid		12 3.3%
Prednisolone	Number Analyzed	366 participants
Prednisolone		11 3.0%
Metformin	Number Analyzed	366 participants
Metformin		10 2.7%
Glucosamine	Number Analyzed	366 participants
Glucosamine		9 2.5%
Pantoprazole	Number Analyzed	366 participants
Pantoprazole		9 2.5%
Piroxicam	Number Analyzed	366 participants
Piroxicam		9 2.5%
Calcium	Number Analyzed	366 participants
Calcium		8 2.2%
Enalapril maleate	Number Analyzed	366 participants
Enalapril maleate		8 2.2%
Ergocalciferol	Number Analyzed	366 participants
Ergocalciferol		8 2.2%
Chymotrypsin	Number Analyzed	366 participants
Chymotrypsin		7 1.9%
Trypsin	Number Analyzed	366 participants
Trypsin		7 1.9%
Glimepiride	Number Analyzed	366 participants
Glimepiride		6 1.6%
Magnesium	Number Analyzed	366 participants
Magnesium		6 1.6%
Calcium carbonate	Number Analyzed	366 participants
Calcium carbonate		5 1.4%
Captopril	Number Analyzed	366 participants
Captopril		5 1.4%
Diclofenac sodium	Number Analyzed	366 participants
Diclofenac sodium		5 1.4%
Pregabalin	Number Analyzed	366 participants
Pregabalin		5 1.4%
Vitamin D	Number Analyzed	366 participants
Vitamin D		5 1.4%
Atorvastatin	Number Analyzed	366 participants
Atorvastatin		4 1.1%
Chondroitin sulphate	Number Analyzed	366 participants
Chondroitin sulphate		4 1.1%
Hydroxychloroquine sulphate	Number Analyzed	366 participants
Hydroxychloroquine sulphate		4 1.1%
Ibuprofen	Number Analyzed	366 participants
Ibuprofen		4 1.1%
Levothyroxine	Number Analyzed	366 participants
Levothyroxine		4 1.1%
Meloxicam	Number Analyzed	366 participants
Meloxicam		4 1.1%
Ranitidine	Number Analyzed	366 participants
Ranitidine		4 1.1%
Silymarin	Number Analyzed	366 participants
Silymarin		4 1.1%
Vitamin B12	Number Analyzed	366 participants
Vitamin B12		4 1.1%
Age at first menstrual period ^[1] Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	244 participants
		13 (12 to 14)
		[1] Measure Analysis Population Description: 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 ^[1] Measure Type: Count of Participants Unit of measure: Participants
Menstruating	Number Analyzed	309 participants
Menstruating		192 62.1%
Premenopausal	Number Analyzed	309 participants
Premenopausal		8 2.6%
Menopausal	Number Analyzed	309 participants
Menopausal		38 12.3%
Post-menopausal	Number Analyzed	309 participants
Post-menopausal		70 22.7%
Missing	Number Analyzed	309 participants
Missing		1 0.3%
		[1] Measure Analysis Population Description: The eligible population for this analysis is the female population (n=309).
Regularity of menstrual periods if menstruating or premenopausal ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
Regular	Number Analyzed	200 participants
Regular		23 11.5%
Irregular	Number Analyzed	200 participants
Irregular		161 80.5%
Missing	Number Analyzed	200 participants
Missing		16 8.0%
		[1] Measure Description: The regularity of menstrual periods in menstruating patients (n=192) and premenopausal patients (n=8). [2] Measure Analysis Population Description: 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 ^[1] Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	358 participants
		2.03 (-0.72 to 4.78)
		[1] Measure Analysis Population Description: 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? Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	366 participants
Yes		51 13.9%
No	Number Analyzed	366 participants
No		315 86.1%
Did the patient take a loading dose of leflunomide before? ^[1] Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	51 participants
Yes		31 60.8%
No	Number Analyzed	51 participants
No		20 39.2%
		[1] Measure Analysis Population Description: 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 ^[1] Median (Inter-Quartile Range) Unit of measure: Months
	Number Analyzed	366 participants
		27.7 (1.63 to 53.78)
		[1] Measure Description: Duration of treatment of rheumatoid arthritis (RA) with medications other than leflunomide until the time of the first study visit.
AEs/SAEs during previous treatment of RA Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	366 participants
Yes		94 25.7%
No	Number Analyzed	366 participants
No		252 68.9%
Missing	Number Analyzed	366 participants
Missing		20 5.5%
X-ray performed for both hands? Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	366 participants
Yes		144 39.3%
No	Number Analyzed	366 participants
No		198 54.1%
Missing	Number Analyzed	366 participants
Missing		24 6.6%
Poor prognostic factors ^[1] Measure Type: Count of Participants Unit of measure: Participants
Bony erosions by radiograph	Number Analyzed	366 participants
Bony erosions by radiograph		90 24.6%
High swollen joint count	Number Analyzed	366 participants
High swollen joint count		136 37.2%
Extra-articular disease	Number Analyzed	366 participants
Extra-articular disease		19 5.2%
Functional limitation (HAQ)	Number Analyzed	366 participants
Functional limitation (HAQ)		240 65.6%
High disease activity	Number Analyzed	366 participants
High disease activity		295 80.6%
High CRP and ESR or high RF and/or anti-CCP	Number Analyzed	366 participants
High CRP and ESR or high RF and/or anti-CCP		237 64.8%
		[1] Measure Description: High disease activity was determined as a measure of composite indices (DAS28, SDAI and/or CDAI).
Weight ^[1] Mean (Standard Deviation) Unit of measure: Kilogram (Kg)
	Number Analyzed	348 participants
		81.3 (15.25)
		[1] Measure Analysis Population Description: The row population (n=348) is different from the overall population (n=366) given that data on weight is missing from 18 patients.
Height ^[1] Mean (Standard Deviation) Unit of measure: Centimeter (cm)
	Number Analyzed	346 participants
		164 (12.19)
		[1] Measure Analysis Population Description: The number analyzed in row (n=346) differs from the overall population (n=366) because height data is missing from 20 patients.
Heart rate ^[1] Mean (Standard Deviation) Unit of measure: Beats/minute
	Number Analyzed	364 participants
		81.7 (8.3)
		[1] Measure Analysis Population Description: The row population (n=364) differs from the overall population (n=366) because data on heart rate was missing from 2 patients.
Temperature ^[1] Mean (Standard Deviation) Unit of measure: Degrees Celsius
	Number Analyzed	359 participants
		37.2 (2.7)
		[1] Measure Analysis Population Description: 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 Mean (Standard Deviation) Unit of measure: mmHg
	Number Analyzed	366 participants
		121.9 (13.66)
Diastolic blood pressure ^[1] Mean (Standard Deviation) Unit of measure: mmHg
	Number Analyzed	365 participants
		78.36 (7.89)
		[1] Measure Analysis Population Description: Data on diastolic blood pressure is missing from 1 patient.
Physical Examination outcome ^[1] Measure Type: Count of Participants Unit of measure: Participants
Normal	Number Analyzed	359 participants
Normal		312 86.9%
Abnormal	Number Analyzed	359 participants
Abnormal		47 13.1%
		[1] Measure Analysis Population Description: 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 ^[1] Measure Type: Count of Participants Unit of measure: Participants
Never	Number Analyzed	364 participants
Never		333 91.5%
Former	Number Analyzed	364 participants
Former		9 2.5%
Current	Number Analyzed	364 participants
Current		22 6.0%
		[1] Measure Analysis Population Description: 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 ^[1] Measure Type: Count of Participants Unit of measure: Participants
Never	Number Analyzed	363 participants
Never		363 100.0%
Yes	Number Analyzed	363 participants
Yes		0 0.0%
Missing	Number Analyzed	366 participants
Missing		3 0.8%
		[1] Measure Analysis Population Description: 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 Measure Type: Count of Participants Unit of measure: Participants
Yes	Number Analyzed	366 participants
Yes		115 31.4%
No	Number Analyzed	366 participants
No		251 68.6%
Comorbidities Measure Type: Count of Participants Unit of measure: Participants
Hypertension	Number Analyzed	366 participants
Hypertension		60 16.4%
Atherosclerosis	Number Analyzed	366 participants
Atherosclerosis		1 0.3%
Coronary artery disease	Number Analyzed	366 participants
Coronary artery disease		3 0.8%
Myocardial infarction	Number Analyzed	366 participants
Myocardial infarction		1 0.3%
Stroke	Number Analyzed	366 participants
Stroke		1 0.3%
Peripheral Vascular Disease	Number Analyzed	366 participants
Peripheral Vascular Disease		1 0.3%
Diabetes Mellitus II	Number Analyzed	366 participants
Diabetes Mellitus II		21 5.7%
Obesity	Number Analyzed	366 participants
Obesity		32 8.7%
Dyslipidemia	Number Analyzed	366 participants
Dyslipidemia		10 2.7%
Respiratory and thoracic disorders	Number Analyzed	366 participants
Respiratory and thoracic disorders		6 1.6%
GIT disorders	Number Analyzed	366 participants
GIT disorders		10 2.7%
Hepatobiliary disorders	Number Analyzed	366 participants
Hepatobiliary disorders		1 0.3%
Nervous system disorders	Number Analyzed	366 participants
Nervous system disorders		5 1.4%
Psychiatric disorders	Number Analyzed	366 participants
Psychiatric disorders		1 0.3%
Reproductive system disorders	Number Analyzed	366 participants
Reproductive system disorders		2 0.5%
Musculoskeletal disoders	Number Analyzed	366 participants
Musculoskeletal disoders		28 7.7%
Autoimmune disease	Number Analyzed	366 participants
Autoimmune disease		10 2.7%
Other	Number Analyzed	366 participants
Other		15 4.1%

Outcome Measures

1.Primary Outcome


Title	Number of Patients With Remission, Low, Moderate or High Disease Activity (in Terms of CDAI Scores) in Visits 1 and 6.
Description	Assessing the clinical efficacy of leflunomide as first-line therapy a...
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Single Arm
Arm/Group Description:	Adult Egyptian patients with active...
Arm/Group Description:	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 Number of Participants Analyzed	366
Measure Type: Count of Participants Unit of Measure: Participants
Disease Severity: Remission : Visit 1	0 0.0%
Disease Severity: Remission : Visit 6	70 19.1%
Disease severity: Low activity : Visit 1	10 2.7%
Disease severity: Low activity : Visit 6	116 31.7%
Disease severity: Moderate activity : Visit 1	53 14.5%
Disease severity: Moderate activity : Visit 6	113 30.9%
Disease severity: High activity : Visit 1	303 82.8%
Disease severity: High activity : Visit 6	67 18.3%

2.Primary Outcome


Title	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.
Description	Assessing the clinical efficacy of leflunomide as first-line therapy a...
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Single Arm
Arm/Group Description:	Adult Egyptian patients with active...
Arm/Group Description:	Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed for 9 months.
Overall Number of Participants Analyzed	366
Measure Type: Count of Participants Unit of Measure: Participants
HAQ score 0.0 - 1 : Visit 1	112 30.6%
HAQ score 0.0 - 1 : Visit 6	318 86.9%
HAQ score 1.1 - 2 : Visit 1	200 54.6%
HAQ score 1.1 - 2 : Visit 6	43 11.7%
HAQ score 2.1 - 3 : Visit 1	54 14.8%
HAQ score 2.1 - 3 : Visit 6	5 1.4%

3.Secondary Outcome


Title	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.
Description	Identifying the safety profile of leflunomide whether used as first-li...
Description	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

Outcome Measure Data

Analysis Population Description

In the safety population (n = 398), 23 adverse events were experienced. These are listed in the table.


Arm/Group Title	Single Arm
Arm/Group Description:	Adult Egyptian patients with active...
Arm/Group Description:	Adult Egyptian patients with active rheumatoid arthritis, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed for 9 months.
Overall Number of Participants Analyzed	398
Measure Type: Count of Participants Unit of Measure: Participants
Hepatic enzyme increased	6 1.5%
Swollen/tender joint count increased	2 0.5%
White blood cell count decreased	2 0.5%
Abdominal discomfort	2 0.5%
Cardiac death	1 0.3%
Anemia	1 0.3%
Bicytopenia	1 0.3%
Flushing/hyperhidrosis/dry mouth/lip disoloration	1 0.3%
Hypertension	1 0.3%
Oropharyngeal pain	1 0.3%
Purpura	1 0.3%
Rheumatoid arthritis	1 0.3%
Scleritis	1 0.3%
Supraventricular tachycardia	1 0.3%
Diarrhea	1 0.3%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.

Arm/Group Title	Single Arm
Arm/Group Description	Adult Egyptian patients with active...
Arm/Group Description	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.
All-Cause Mortality
	Single Arm
	Affected / at Risk (%)
Total	0/398 (0.00%)
Serious Adverse Events Serious Adverse Events
	Single Arm
	Affected / at Risk (%)
Total	0/398 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Single Arm
	Affected / at Risk (%)
Total	20/398 (5.03%)
Blood and lymphatic system disorders
White blood cell count decreased ^†	2/398 (0.50%)
Anemia ^†	1/398 (0.25%)
Bicytopenia ^†	1/398 (0.25%)
Cardiac disorders
Cardiac death ^†	1/398 (0.25%)
Hypertension ^†	1/398 (0.25%)
Supraventricular tachycardia ^†	1/398 (0.25%)
Eye disorders
Scleritis ^†	1/398 (0.25%)
Gastrointestinal disorders
Diarrhea ^†	1/398 (0.25%)
General disorders
Abdominal discomfort ^†	2/398 (0.50%)
Flushing/hyperhidrosis/dry mouth/lip discoloration ^†	1/398 (0.25%)
Oropharyngeal pain ^†	1/398 (0.25%)
Hepatobiliary disorders
Hepatic Enzyme increase ^†	6/398 (1.51%)
Immune system disorders
Rheumatoid Arthritis ^†	1/398 (0.25%)
Musculoskeletal and connective tissue disorders
Swollen/Tender joint count increased ^†	2/398 (0.50%)
Skin and subcutaneous tissue disorders
Purpura ^†	1/398 (0.25%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Writer
Organization:	DataClin
Phone:	(+2) 01001566602
EMail:	mariam.abdalla@dataclin.com

Layout table for additonal information

Responsible Party:	Adel Mahmoud Elsayed, Eva Pharma
ClinicalTrials.gov Identifier:	NCT03599986
Other Study ID Numbers:	EVA_CLEAR_11022017
First Submitted:	January 31, 2018
First Posted:	July 26, 2018
Results First Submitted:	May 5, 2020
Results First Posted:	June 30, 2020
Last Update Posted:	June 30, 2020

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