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NCT Number: NCT03348046

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Hamza Hospital, Amman, Jordan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biosimilar Infliximab

Drug

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

Other names: Remsima®

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

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

Acronym: PASSRRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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