Back to resultsEffect of Some Drugs on Rheumatoid Arithritis Activity
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Rupatadine
Montelukast
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis
Exclusion Criteria:
- liver or renal disease
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
No intervention
Rupatadine
Montelukast
Arm Description
No intervention
Rupatadine 10 mg once daily.
Montelukast 10 mg daily
Outcomes
Primary Outcome Measures
se level of IL-17
change in level of IL-17
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03770923
Brief Title
Effect of Some Drugs on Rheumatoid Arithritis Activity
Official Title
Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effect of Some Drugs on Rheumatoid Arithritis Activity.
Detailed Description
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Rupatadine
Arm Type
Active Comparator
Arm Description
Rupatadine 10 mg once daily.
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
Montelukast 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Rupatadine 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Montelukast 10 mg daily
Primary Outcome Measure Information:
Title
se level of IL-17
Description
change in level of IL-17
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis
Exclusion Criteria:
liver or renal disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, Ph D
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar k Hegazy, Prof
Organizational Affiliation
Head of Clinical Pharmacy Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek M Mostafa, Prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Salwa E Abd El-Ghany, Prof
Organizational Affiliation
Rheumatology Dept. - Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fedaa AK Kotkata, Msc
Organizational Affiliation
Clinical pharmacy Department-Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fedaa Kotkata, Msc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34218304
Citation
Mostafa TM, Hegazy SK, El-Ghany SEA, Kotkata FAE. Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis. Eur J Clin Pharmacol. 2021 Dec;77(12):1825-1834. doi: 10.1007/s00228-021-03181-2. Epub 2021 Jul 4.
Results Reference
derived
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Effect of Some Drugs on Rheumatoid Arithritis Activity
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