Outcomes of Biological Therapy on Rheumatoid Arthritis

March 4, 2022 updated by: Nesma Mansour Mohamed, Sohag University

Outcomes of Different Biological Therapy on Rheumatoid Arthritis

Evaluate effect of biological therapy on activity of RA compared to usual DMARDs

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparison between RA activity in both groups who recieved biological and DMARDS therapy

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

RA patients

Description

Inclusion Criteria:

  • RA patients

Exclusion Criteria:

  • any other connective tissue disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA patients recieved biological therapy
RA patients recieved different biological therapy
RA patients recieved different DMARDS
Drug: Biological Drug
Different biological drugs
Other Names:
  • DMARDS as hydroquinone and methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in activity of rheumatoid arthritis
Time Frame: After 3 months of treatment
By DAS 28; it include 28 tender and swollen joints, laboratory test (ESR) and visual analogue score, if it higher than 5.1 it mean high disease activity and if lower than 3.2 it mean low activity and consider remission if lower than 2.6
After 3 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of RA
Time Frame: 3 months after treatment
MHAQ.scores include questionnaire from eight activities of daily living and range from 0 to 3 and lower scores mean better function state and high scores mean worse function state
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: N M AHM, Specialist, Sohag faculty of medicine
  • Principal Investigator: M M AHM, Sohag faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-02-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe