NCT05963048

Brief Summary

All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

December 25, 2022

Last Update Submit

November 13, 2023

Conditions

Interstitial Lung DiseaseScleroderma

Outcome Measures

Primary Outcomes (1)

  • forced vital capacity

    pulmonary function test

    6 months

Secondary Outcomes (2)

  • computed tomography chest

    1 year

  • modified rodnan skin score

    6 months

Study Arms (2)

Rituxmab

EXPERIMENTAL

1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year

Drug: Rituximab

IL-6 inhibitor

EXPERIMENTAL

6 mg/kg IV infusion every month not exceed 600 mg for 1 year

Drug: IL6 inhibitor

Interventions

RituximabDRUG

IV infusion 1000 mg

Also known as: Rituxan
Rituxmab
IL6 inhibitorDRUG

6 mg/kg I V infusion monthly

Also known as: Actemra
IL-6 inhibitor

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active ILD scleroderma

You may not qualify if:

  • abnormal liver enzymes renal impairment neutropenia \<1000 cells/mm3 thrombocytopenia \< 50,000 cells/mm3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Hassanien

Asyut, Yes, 7111, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialScleroderma, Diffuse

Interventions

Rituximabtocilizumab

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesScleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Manal Hassanien, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
participant and outcome assrssor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 25, 2022

First Posted

July 27, 2023

Study Start

December 1, 2021

Primary Completion

December 30, 2022

Study Completion

June 1, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

after finishing

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
one year
Access Criteria
after finishing the study

Locations

EG(1)