Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan (PASSRRA)

March 3, 2020 updated by: Hikma Pharmaceuticals LLC

Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and health assessment in each cohort will be measured and compared

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

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

Study Locations

  • Jordan
      • Amman, Jordan
        • Prince Hamza Hospital
      • Irbid, Jordan
        • Jordan University of Science and Technology- King Abdallah University Hospital

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

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®
Time Frame: 8.5 months
Rate of AEs leading to permanent treatment discontinuation and rate of clinically relevant changes in laboratory tests will be calculated
8.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean changes in disease activity scores (DAS28)- Number of swollen joints
Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured. The number of swollen joints will be assessed.
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
Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured. The number of tender joints will be assessed.
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)
Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured.

ESR (Erythrocyte Sedimentation Rate) will be measured in mm/hr.
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)
Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured.

Patients will be asked to make a global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS) measured by units on scale.

Number of swollen and tender joints, Erythrocyte Sedimentation Rate and global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS) are then fed into a complex mathematical formula to produce the overall disease activity score.

The DAS28 provides a number on a scale from 0 to 10 indicating the current activity of the RA of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
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)
Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The reported data from patients include the amount of difficulty they have in performing some of their activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3).
8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses

Collaborators and Investigators

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

Sponsor

Hikma Pharmaceuticals LLC

Collaborators

Syneos Health

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 (Actual)

March 23, 2017

Primary Completion (Actual)

April 14, 2019

Study Completion (Actual)

April 14, 2019

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMS-JOR-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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