N/A
Completed N=334
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
Rheumatoid Diseases · Rheumatoid Arthritis · Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT02605642 ↗
Enrolled (actual)
334
Serious AEs
8.8%
Results posted
Jan 2020
Primary outcomePrimary: Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) — 404.10; 542.30 days
Summary
To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are:
* To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) |
404.10; 542.30 | — |
| PRIMARY Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study |
52.928; 189.142; 35.039; 159.376; 33.084; 133.979 | — |
| PRIMARY Initial Dose of CT-P13 Infusion Administered to Participants |
3.00; 4.00 | — |
| PRIMARY Number of Participants by Initial Frequency of CT-P13 Infusion Received |
3; 1; 79; 42; 73; 44 | — |
| PRIMARY Total Dose of CT-P13 Infusion Received During Observation Period |
35.00; 46.50 | — |
| PRIMARY Number of Participants With Change in CT-P13 Infusion Dose |
40; 8 | — |
| PRIMARY Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) |
28; 2; 27; 5; 48; 12 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) |
97; 29; 19; 10; 24; 8 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 |
4.033; 2.641; -1.269; 0.210; -0.642; -0.432 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 |
3.755; 2.351; -0.913; 0.152; -0.006; 0.259 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 |
4.63; 3.06; -1.00; 0.01; -0.87; 0.06 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 |
3.153; 2.151; -0.875; -0.023; -0.379; -0.452 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 |
4.17; 2.89; -0.72; 0.20; -1.01; 0.18 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 |
0.956; 0.646; -0.216; 0.026; -0.207; -0.043 | — |
| SECONDARY Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 |
62.7; 70.0; 6.0; 0.2; 4.2; 1.0 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 |
0.627; 0.757; 0.097; 0.004; 0.106; -0.002 | — |
| SECONDARY Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 |
37.018; 41.865; 2.679; 0.638; 3.988; 0.683 | — |
| SECONDARY Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 |
47.154; 52.152; 2.603; -0.412; 1.435; 0.119 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 |
34.9; 18.4; -13.4; 0.6; -19.2; -1.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥18 years old at the time of enrollment
- Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator
Exclusion Criteria
- Any reported contraindications for Inflectra according to the SmPC or Product Monograph
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT02605642). 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. Informational only — not medical advice.