N/A
N=115
Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD) · Crohn's Disease (CD) · Ulcerative Colitis (UC)
Bottom Line
View on ClinicalTrials.gov: NCT03801928 ↗Enrolled (actual)
115
Serious AEs
16.5%
Results posted
Mar 2021
Primary outcome: Primary: Average Dose of Inflectra at Visit 1 — 457.28; 585.71; 579.44; 449.76 milligram
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Inflectra (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Dose of Inflectra at Visit 1 |
457.28; 585.71; 579.44; 449.76; 521.83; 534.90 | — |
| PRIMARY Average Dose of Inflectra at Visit 2 |
491.66; 535.29; 662.36; 491.62; 506.97; 575.00 | — |
| PRIMARY Average Dose of Inflectra at Visit 3 |
556.34; 531.25; 647.67; 517.87; 544.40; 621.00 | — |
| PRIMARY Average Dose of Inflectra at Visit 4 |
409.28; 552.00; 450.00; 536.12; 553.20; 610.15 | — |
| PRIMARY Mean Number of Inflectra Infusions at Visit 1 |
1.56; 1.00; 1.44; 1.43; 1.11; 1.70 | — |
| PRIMARY Mean Number of Inflectra Infusions at Visit 2 |
2.06; 1.76; 2.38; 1.95; 1.47; 2.00 | — |
| PRIMARY Mean Number of Inflectra Infusions at Visit 3 |
1.56; 1.38; 2.20; 1.47; 1.40; 1.40 | — |
| PRIMARY Mean Number of Inflectra Infusions at Visit 4 |
2.56; 3.00; 2.50; 3.11; 3.08; 2.75 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire for Absenteeism Score at Visit 2, 3 and 4 |
NA; NA; NA; NA; -3.68; NA | — |
| SECONDARY Change From Baseline in WPAI Questionnaire for Presenteeism Score at Visit 2, 3 and 4 |
-23.7; -13.18; NA; NA; 3.91; NA | — |
| SECONDARY Change From Baseline in WPAI Questionnaire for Overall Work Impairment Score at Visit 2, 3 and 4 |
-22.21; -14.39; NA; NA; 2.33; NA | — |
| SECONDARY Change From Baseline in WPAI Questionnaire for Daily Regular Activity Impairment Score at Visit 2, 3 and 4 |
-35.51; -14.66; NA; -17.27; 3.75; NA | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Convenience Score at Visit 2, 3 and 4 |
7.08; -0.16; NA; 0.75; 0.57; NA | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Effectiveness Score at Visit 2, 3 and 4 |
23.33; 3.27; NA; 12.55; -10.73; 12.44 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM vII) for Side Effects Score at Visit 2, 3 and 4 |
NA; 1.23; NA; 15.32; -1.19; NA | — |
| SECONDARY Mean of Total Number of Hospitalizations at Visit 1, 2, 3 and 4 |
0.17; 0.00; 0.33; 0.24; 0.00; 0.40 | — |
| SECONDARY Mean of Total Number of Overall Emergency Department (ED) Visits at Visit 1, 2, 3 and 4 |
0.22; 0.10; 0.11; 0.14; 0.03; 0.20 | — |
| SECONDARY Mean of Total Number of Outpatient Visits at Visit 1, 2, 3 and 4 |
2.06; 1.10; 4.22; 1.05; 0.78; 1.80 | — |
| SECONDARY Mean of Total Number of Gastroenterology (GE) Outpatient Visits at Visit 1, 2, 3 and 4 |
0.94; 0.48; 2.67; 0.90; 0.28; 1.00 | — |
| SECONDARY Mean of Total Number of General Practitioner (GP) Outpatient Visits at Visit 1, 2, 3 and 4 |
0.33; 0.33; 1.33; 0.05; 0.22; 0.10 | — |
| SECONDARY Number of Participants With Crohn's Disease Remission at Visit 1, 2, 3 and 4 |
13; 28; 7; 16; 23; 8 | — |
| SECONDARY Number of Participants With Ulcerative Colitis Remission at Visit 1, 2, 3 and 4 |
1; 15; 1; 14; 16; 4 | — |
| SECONDARY Number of Participants With Crohn's Disease Response at Visit 1, 2, 3 and 4 |
0; 0; 0; 4; 3; 3 | — |
| SECONDARY Number of Participants With Ulcerative Colitis Response at Visit 1, 2, 3 and 4 |
0; 0; 0; 12; 2; 4 | — |
| SECONDARY Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Visit 2, 3 and 4 |
17.52; 4.96; NA; 6.73; -0.19; 12.72 | — |
| SECONDARY Change From Baseline in Quality of Life Visual Analog Scale (VAS) at Visit 2, 3 and 4 |
16.68; 2.31; NA; 6.16; 0.67; 6.83 | — |
| SECONDARY Number of Participants Categorized on the Basis of Montreal Classification by Extent: Ulcerative Colitis |
3; 1; 1; 6; 3; 4 | — |
| SECONDARY Number of Participants Categorized on the Basis of Montreal Classification by Location and Behavior: Crohn's Disease |
7; 12; 3; 6; 12; 4 | — |
| SECONDARY Partial Mayo Score (PMS) at Baseline for Participants With Ulcerative Colitis |
5.67; 1.38; 6.00 | — |
| SECONDARY Harvey Bradshaw Index (HBI) at Baseline for Participants With Crohn's Disease |
3.95; 3.11; 3.57 | — |
| SECONDARY Number of Participants With Infections |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Malignancy and Lymphoma |
0; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Participants With Infusion-related Reactions |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Any Serious Adverse Event |
0; 3; 1; 5; 8; 2 | — |
Summary
This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.
Eligibility Criteria
Inclusion Criteria
Patients must meet all of the following criteria to be eligible for inclusion in the study:
- Patients with confirmed diagnosis of Ulcerative Colitis or Crohn's Disease.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Patient eligible to receive INFLECTRA for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible).
Exclusion Criteria
-Patients meeting any of the following criteria will not be included in the study:
- Patient previously failed treatment with REMICADE or INFLECTRA/CT P13.
- Any reported contraindications for INFLECTRA/CT P13 or REMICADE.
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
Data sourced from ClinicalTrials.gov (NCT03801928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.