JAK2 Mutation May Predict Response and Guide First Line Treatment in Rheumatoid Arthritis
Primary Purpose
Response Assessment in Newly Diagnosed RA Patients at 3rd Month Was Evaluated by DAS28 and ACR in Relation to JAK Expression
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
JAK expression
Sponsored by
About this trial
This is an interventional other trial for Response Assessment in Newly Diagnosed RA Patients at 3rd Month Was Evaluated by DAS28 and ACR in Relation to JAK Expression
Eligibility Criteria
Inclusion Criteria:
- New case RA patients
- good liver and renal function
Exclusion Criteria:
- Other autoimmune diss
- Malignancy
- Active viral infection
- pregnancy and lactation
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RA patients
control
Arm Description
newly diagnosed RA will started therapy with conventional synthetic DMARDs (including methotrexate)
JAK2 mutation assesment by PCR
Outcomes
Primary Outcome Measures
JAK2 mutation expression in newly diagnosed RA patients
Impact of pretreatment JAK2 mutation on response of Rheumatoid Arthritis patients to first line csDMARDS.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04667988
Brief Title
JAK2 Mutation May Predict Response and Guide First Line Treatment in Rheumatoid Arthritis
Official Title
JAK2 Mutation May Predict Response and Guide First Line Treatment in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study included 76 newly diagnosed RA patients and 50 matched controls. Basal JAK2 mutation was assessed by PCR in blood samples, TNF-α and IL 6 were measured by ELISA in serum of patients and controls. All patients started therapy with conventional synthetic DMARDs (including methotrexate). Response assessment at 3rd month was evaluated by DAS28 and ACR response criteria. JAK2 mutation was correlated with different clinical and laboratory parameters of patients.
Detailed Description
PCR detection of the JAK-2 V617F mutation using ASO specific PCR Genetic marker:
The detection of jak2 V617F mutation were done by using the following primers (JAK2 Reverse: 5' CTGAATAGTCCTACAGTGTTTTCAGTTTCA 3', JAK2 Forward (specific): 5' AGCATTTGGTTTTAAATTATGGAGTATATT 3' and JAK2 Forward (internal control): 5' ATCTATAGTCATGCTGAAAGTAGGAGAAAG 3'). Cycling conditions were 35 cycles with annealing temperature 58.5oC flowed by agarose gel 2% electrophoresis for bands detections.
All patients started treatment by conventional synthetic DMARDs (including methotrexate). Response assessment at 3rd month was evaluated by DAS28 and ACR response criteria. JAK2 mutation was correlated with different clinical and laboratory parameters of patients.
The Disease Activity Score (DAS) and the DAS28 have been developed to measure disease activity in RA both in daily clinical practice as well as in clinical trials on a group as well as individual level. The DAS/DAS28 is a continuous measure of RA disease activity that combines information from swollen joints, tender joints, acute phase response and general health The DAS28 is a measure of disease activity in rheumatoid arthritis (RA). DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. questionnaires (e.g. the HAQ which assesses function), X-rays, and newer imaging techniques such as ultrasound and MRI.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Response Assessment in Newly Diagnosed RA Patients at 3rd Month Was Evaluated by DAS28 and ACR in Relation to JAK Expression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RA patients
Arm Type
Experimental
Arm Description
newly diagnosed RA will started therapy with conventional synthetic DMARDs (including methotrexate)
Arm Title
control
Arm Type
Experimental
Arm Description
JAK2 mutation assesment by PCR
Intervention Type
Diagnostic Test
Intervention Name(s)
JAK expression
Intervention Description
JAK2 assessment in blood by PCR
Primary Outcome Measure Information:
Title
JAK2 mutation expression in newly diagnosed RA patients
Description
Impact of pretreatment JAK2 mutation on response of Rheumatoid Arthritis patients to first line csDMARDS.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
New case RA patients
good liver and renal function
Exclusion Criteria:
Other autoimmune diss
Malignancy
Active viral infection
pregnancy and lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Elbaiomy, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Asses response of treatment in RA patients in relation to JAK2 mutation
Learn more about this trial
JAK2 Mutation May Predict Response and Guide First Line Treatment in Rheumatoid Arthritis
We'll reach out to this number within 24 hrs