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National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life (ReFLECT)

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ClinicalTrials.gov Identifier: NCT02925338
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.


Condition or disease Intervention/treatment
Crohn Desease Ulcerative Colitis Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Other: QOL questionaire

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.
Actual Study Start Date : October 19, 2016
Estimated Primary Completion Date : September 23, 2020
Estimated Study Completion Date : April 29, 2021


Group/Cohort Intervention/treatment
Patients treated with Inflectra Other: QOL questionaire
Health assessment questionnaire disability index for rheumatoide polyarthritis questionnair




Primary Outcome Measures :
  1. Percent of patients without treatment failure during the 2 year follow-up period [ Time Frame: Baseline through Month 24 ]

    Response to treatment will be described indirectly and expressed as percentage of patients without treatment failure during the 2 year follow up period

    o Treatment failure = definitive discontinuation of InflectraTM for "Loss of efficacy" or "Intolerance", or AE related to InflectraTM resulting in death


  2. Average time between diagnosis and inclusion. [ Time Frame: Baseline ]
  3. • Average Duration of previous biotherapies [ Time Frame: Baseline ]
  4. Mean weight of patients enrolled [ Time Frame: Baseline ]
  5. Mean age of patients enrolled [ Time Frame: Baseline ]
  6. Average time between diagnosis and 1st Inflectra infusion [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Mean dose administered (in mg) [ Time Frame: baseline to 24 month ]
    osology of infusion No.1+⋯+Posology of infusion No.X/Number of infusions listed during period in question

  2. Cumulative dose (mg) [ Time Frame: baseline to 24 month ]
    Cumulative dose = Sum of doses during period in question

  3. Mean infusion time (minutes) [ Time Frame: baseline to 24 month ]
    Duration of infusion No.1 +⋯+Duration of infusion No.X /Number of infusions times listed during period in question

  4. Mean post-infusion monitoring time at hospital (minutes) [ Time Frame: baseline to 24 month ]
    Duration of monitoring No.1 +⋯+Duration of monitoring No.X/Number of monitoring times listed during period in question

  5. Mean time between infusions (weeks) [ Time Frame: baseline to 24 month ]
    ∑_(i=1)^x〖(Date of infusion No.i-Date of infusion No.(i-1))/7〗/Number of infusions listed during period in question -1

  6. Absolute variation of mean global disease assessment compared with baseline [ Time Frame: baseline to 24 month ]
    Mean global disease assessment score during period in question - Global disease assessment score at baseline

  7. Absolute variation of mean fatigue score compared with baseline [ Time Frame: baseline to 24 month ]
    Mean fatigue score during period in question - Fatigue score at baseline

  8. Absolute variation of mean of each activity index score compared with baseline [ Time Frame: baseline to 24 month ]
    Mean activity index score during period in question - activity index score at baseline

  9. Absolute variation of endoscopic score compared with baseline [ Time Frame: baseline to 24 month ]
    Endoscopic score at visit X - Endoscopic score at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis

Criteria

Inclusion Criteria:

  • Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
  • Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
  • Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.

Exclusion Criteria:

  • Patients who refuse access to their medical file for collection of: their medical data
  • Patients not treated with Inflectra™.
  • Patients treated with Inflectra™ for psoriasis.
  • Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
  • Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
  • Patients with moderate to severe heart failure (NYHA III/IV)

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): NCT02925338


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 80 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02925338    
Other Study ID Numbers: C1231004
REFLECT ( Other Identifier: Alias Study Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Additional relevant MeSH terms:
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Psoriasis
Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Colitis, Ulcerative
Joint Diseases
Musculoskeletal Diseases
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis