NCT05267431

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 21, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

February 14, 2022

Last Update Submit

March 4, 2022

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

  • Change in activity of rheumatoid arthritis

    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 Outcomes (1)

  • Activity of RA

    3 months after treatment

Study Arms (2)

RA patients recieved biological therapy

RA patients recieved different biological therapy

RA patients recieved different DMARDS

RA patients recieved different DMARDS

Drug: Biological Drug

Interventions

Biological DrugDRUG

Different biological drugs

Also known as: DMARDS as hydroquinone and methotrexate
RA patients recieved different DMARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

RA patients

You may qualify if:

  • RA patients

You may not qualify if:

  • any other connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Biological ProductsAntirheumatic AgentshydroquinoneMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complex MixturesTherapeutic UsesPharmacologic ActionsChemical Actions and UsesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • N M AHM, Specialist

    Sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

  • M M AHM

    Sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

N M Mansour

CONTACT

01004517558nesmamansour971@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Outcomes of different biological therapy on rheumatoid arthritis

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 4, 2022

Study Start

June 1, 2022

Primary Completion

May 1, 2023

Study Completion

October 1, 2023

Last Updated

March 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)