NCT03348046

Brief Summary

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or intervention(s) additional to the daily practice will be performed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

March 23, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

November 16, 2017

Last Update Submit

March 3, 2020

Conditions

Rheumatoid Arthritis

Keywords

InfliximabRemsimaBiosimilarAutoimmune DiseaseRheumatoid ArthritisCohort StudyDisease modifying anti-rheumatic drugsTumor necrosis factor-alpha inhibitors

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®

    Rate of AEs leading to permanent treatment discontinuation and rate of clinically relevant changes in laboratory tests will be calculated

    8.5 months

Secondary Outcomes (5)

  • Mean changes in disease activity scores (DAS28)- Number of swollen joints

    8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

  • Mean changes in disease activity scores (DAS28)-Number of tender joints

    8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

  • Mean changes in disease activity scores (DAS28)-ESR (Erythrocyte Sedimentation Rate)

    8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

  • Mean changes in disease activity scores (DAS28)- Global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS)

    8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

  • Mean changes in Disability Index of the Health Assessment Questionnaire (HAQ-DI)

    8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

Interventions

Biosimilar InfliximabDRUG

A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg

Also known as: Remsima®

Eligibility Criteria

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

Patients will be recruited from rheumatology outpatient clinics of 2 hospitals in Jordan

You may qualify if:

  • Adult patients (age ≥18 years)
  • Biologic naïve patients with active RA diagnosed according to the revised 1987 American College of Rheumatology (ACR) (Arnett et al. 1988) or 2010 ACR / European League Against Rheumatism (EULAR) Rheumatoid Arthritis classification criteria (Aletaha et al. 2010)
  • Patients should be receiving a stable dose Methotrexate (MTX) for at least 3 months prior to enrolment, and still have active disease defined as erythrocyte sedimentation rate (ESR) ≥28 mm/h and swollen and tender joints ≥ 6
  • Absence of tuberculosis demonstrated by negative chest X-ray

You may not qualify if:

  • Patient \<18 years
  • Previous treatment with biologics
  • Patients who meet any of the contraindications to the administration of infliximab
  • Previous or concurrent malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince Hamza Hospital

Amman, Jordan

Location

Jordan University of Science and Technology- King Abdallah University Hospital

Irbid, Jordan

Location

MeSH Terms

Conditions

Arthritis, RheumatoidAutoimmune Diseases

Interventions

CT-P13

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 20, 2017

Study Start

March 23, 2017

Primary Completion

April 14, 2019

Study Completion

April 14, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

JO(2)