Rheumatoid ArthritisPASSRRANCT03348046
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
An observational study of Rheumatoid Arthritis, run by Hikma Pharmaceuticals LLC at 2 sites in Jordan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Biosimilar Infliximab
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 2 sitesJordan
- Study dates
- 23 Mar 2017to 14 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from rheumatology outpatient clinics of 2 hospitals in Jordan
Who may be able to join
- 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
Who cannot join
- Patient <18 years
- Previous treatment with biologics
- Patients who meet any of the contraindications to the administration of infliximab
- Previous or concurrent malignancies
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Prince Hamza Hospital
Amman
Jordan University of Science and Technology- King Abdallah University Hospital
Irbid
About this study
Official title: 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
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Biosimilar Infliximab
- Keywords
- Infliximab, Remsima, Biosimilar, Autoimmune Disease, Rheumatoid Arthritis, Cohort Study, Disease modifying anti-rheumatic drugs, Tumor necrosis factor-alpha inhibitors
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosimilar InfliximabDrug
Also called Remsima®
A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8.5 months
Secondary outcomes (5)
Mean changes in disease activity scores (DAS28)- Number of swollen joints
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start23 Mar 2017
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348046
- Sponsor's protocol ID
- RMS-JOR-2015-01
- Acronym
- PASSRRA
- Status last verified
- Mar 2020
- First submitted
- 16 Nov 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
- ClinicalTrials.gov ID
- NCT03348046
- Acronym / sponsor ID
- PASSRRA / RMS-JOR-2015-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Infliximab, Remsima, Biosimilar, Autoimmune Disease, Rheumatoid Arthritis, Cohort Study, Disease modifying anti-rheumatic drugs, Tumor necrosis factor-alpha inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from rheumatology outpatient clinics of 2 hospitals in Jordan
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patient <18 years
- Previous treatment with biologics
- Patients who meet any of the contraindications to the administration of infliximab
- Previous or concurrent malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosimilar InfliximabAlso: Remsima®A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg | Drug | – |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hikma Pharmaceuticals LLC at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima® (time frame: 8.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.