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

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ClinicalTrials.gov Identifier: NCT03348046
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Hikma Pharmaceuticals LLC

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Biosimilar Infliximab

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
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab


Intervention Details:
  • Drug: Biosimilar Infliximab
    A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
    Other Name: Remsima®


Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from rheumatology outpatient clinics of 2 hospitals in Jordan
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348046


Contacts
Contact: Hikma Pharmaceuticals +962 6 5805430 ext 11663 medical-information@hikma.com

Locations
Jordan
Prince Hamza Hospital Recruiting
Amman, Jordan
Jordan University of Science and Technology- King Abdallah University Hospital Recruiting
Irbid, Jordan
Sponsors and Collaborators
Hikma Pharmaceuticals LLC
INC Research

Responsible Party: Hikma Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03348046     History of Changes
Other Study ID Numbers: RMS-JOR-2015-01
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hikma Pharmaceuticals LLC:
Infliximab
Remsima
Biosimilar
Autoimmune Disease
Rheumatoid Arthritis
Cohort Study
Disease modifying anti-rheumatic drugs
Tumor necrosis factor-alpha inhibitors

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents