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Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD (CHAMELEON)

Primary Purpose

Crohn's Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Infliximab-Dyyb
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Infliximab, Biosimilar, Remsima, Subcutaneous, Intravenous

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years or older Moderate to severe Crohn's disease (Crohn's disease activity index 220 to 450) Ileocolonic Crohn's disease (CD) with Simple Endoscopic Score for Crohn Disease ≥6 or ileal or colonic CD with with Simple Endoscopic Score for Crohn Disease ≥4 and ulcer score ≥1 in at least one segment Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL Patients who have never been to exposed to any biologic agent Patients who are non-responsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy Patients who gave a voluntary informed consent Exclusion Criteria: Patients who have a history of hypersensitivity to humanized proteins Patients ever treated with corticosteroids within 8 weeks of screening date a) Symptomatic intestinal stricture, b) Symptomatic anal stricture, c) Untreated intra-abdominal abscess, d) Untreated perianal abscess, e) Abdominal surgery within 6 months, f) Patients who are expected to require intestinal surgeries during study period - However, the following patients can be included: from baseline, 4 weeks or more after proper drainage of perianal abscess and from baseline, 8 weeks or more after proper drainage of intra-abdominal abscess Active tuberculosis. However, the following patients can be included: Patients who were diagnosed with tuberculosis, but were properly treated with anti-tuberculosis therapy according to the standard guidelines and who were confirmed to be cured. Latent tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray, PPD (Purified Protein Derivative) skin test or interferon gamma release assay (IGRA) by a pulmonology specialist. However, patients with LTBI who finished proper treatment for LTBI for 4 weks and who are going to complete LTBI treatment. HBsAg (Hepatitis B virus surface antigen)-positivity. Patients with negative HBsAg, but positive IgG anti-HBc (Immunoglobulin G anti-Hepatitis B core antibody) should be tested for HBV (hepatitis B virus) DNA real time quantitative PCR (polymerase chain reaction). If HBV DNA real time quantitative PCR ≥10 IU/mL should be excluded. Anti-HCV (hepatitis C virus) antibody-positivity History of HIV (human immunodeficiency virus) infection of positivity for anti-HIV Heart disease of NYHA (New York Heart Association) Class III/IV Active infection Malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) or history of colonic or small bowel dysplasia within 5 years Pregnancy or lactating woman Patients who are not applying proper contraceptive measures and patients who do not have a plan for proper contraceptive measures for at least 6 months after the last dose of infliximab (oral, parenteral, or implantable hormonal contraceptives, diaphragm, condom, intra-uterine device, or abstinence are accepted as proper contraceptive methods. Patients who are decided to be not proper to be enrolled into the study by investigators.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Non-response to SC infliximab at week 30 and switched to infliximab IV 10 mg/kg every 8 weeks

Response to SC infliximab at week 30 and then, switched to infliximab IV 5 mg/kg every 8 weeks

Response to SC infliximab at week 30 and then, continued infliximab SC 120 mg every 2 weeks

Arm Description

Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 1] Non-responders at week 30: Switched to infliximab IV 10 mg/kg every 8 weeks

Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 2] Response to SC infliximab at week 30 and then, randomly allocated to infliximab IV 5 mg/kg every 8 weeks

Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 3] Response to SC infliximab at week 30 and then, randomly allocated to infliximab SC 120 mg every 2 weeks

Outcomes

Primary Outcome Measures

Deep remission rate of Arm 3 compared with Arm 2
Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index) <150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation. CDAI can range from 0 to 600 and a higher value mean more clinically active disease. SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity. The non-inferiority of Arm 3 compared with Arm 2 will be test and the non-inferiority margin will be set as "-20%".

Secondary Outcome Measures

Deep remission rate of Arm 3 compared with Arm 1
Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index)<150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation. CDAI can range from 0 to 600 and a higher value mean more clinically active disease. SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity. The non-inferiority of Arm 3 compared with Arm 1 will be test and the non-inferiority margin will be set as "-20%".
Corticosteroid-free endoscopic remission rate of each arm
All of these 2 criteria should be met to be classified as a corticosteroid-free endoscopic remitter: (1) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (2) No systemic corticosteroids use for at least 8 weeks before evaluation SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity.
Corticosteroid-free complete mucosal healing rate of each arm
All of these 2 criteria should be met to be classified as an achiever of corticosteroid-free complete mucosal healing: (1) No visible ulcers (including aphthous ulcers) in ileocolonoscopy, (2) No systemic corticosteroids use for at least 8 weeks before evaluation
Corticosteroid-free clinical response (CDAI-70) rate of each arm
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-70): (1) Reduction of CDAI (Crohn's disease activity index) 70 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Corticosteroid-free clinical response (CDAI-100) rate of each arm
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-100): (1) Reduction of CDAI (Crohn's disease activity index) 100 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Corticosteroid-free clinical remission rate of each arm
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical remitter: (1) CDAI (Crohn's disease activity index) < 150, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Corticosteroid-free biochemical remission rate of each arm
All of these 2 criteria should be met to be classified as a biochemical remitter: (1) Both fecal calprotectin<250 µg/g and serum CRP (C-reactive protein) <0.5 mg/dL, (2) No systemic corticosteroids use for at least 8 weeks before evaluation
Rate of anti-drug antibody positivity in each arm
Proportion of patients with a positive anti-infliximab antibody compared with the baseline
The proportion of patients with treatment-related adverse events
Comparing the proportions of patients having any adverse events, serious adverse events, serious infections, and all types of adverse events as assessed by CTCAE v6.0

Full Information

First Posted
September 10, 2023
Last Updated
October 5, 2023
Sponsor
Asan Medical Center
Collaborators
Seoul National University Hospital, Severance Hospital, Kyung Hee University Hospital, Kyungpook National University Hospital, Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06064864
Brief Title
Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
Acronym
CHAMELEON
Official Title
Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Seoul National University Hospital, Severance Hospital, Kyung Hee University Hospital, Kyungpook National University Hospital, Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority trial is to test efficacy and safety of formulation switching between subcutaneous (SC) infliximab and intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease (CD). The primary endpoint of this study is deep remission at week 54. The main questions this study aims to answer are: Question-1) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (5mg/kg every 8 weeks) in terms of deep remission at week 54? Question-2) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (10mg/kg every 8 weeks) in terms of deep remission at week 54?
Detailed Description
Remsima (CT-P13) is the first biosimilar of infliximab and its intravenous (IV) formulation has been used for patients with active Crohn's disease (CD). Recently, subcutaneous (SC) formulation of Remsima (Remsima SC) was developed and approved by the Korean FDA (Food and Drug Administration). However, until now, besides a registration trial, real-life experiences of Remsima SC is still limited and the efficacy and safety of switching from SC to IV Remsima is still unknown. In this study, patients with moderately to severely active CD who achieve clinical response to SC Remsima at week 30 (IV Remsima 5mg/kg at week 0 and 2, followed by SC Remsima 120mg every 2 weeks from week 6) will be randomly (1:1) assigned to IV Remsima group (Arm 2) or to continued SC Remsima group (Arm 3). Non-responders at week 30 will be allocated to Arm 1 (IV Remsima 10 mg/kg). The primary endpoint is the non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate at week 54. The secondary endpoint is the non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate at week 54. The non-inferiority margin is set as -20% and a total of 100 patients will be enrolled. Through this study, the investigators aim to provide the clinical evidence for selecting the most optimal formulation of infliximab according to therapeutic response among Korean patients with CD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Infliximab, Biosimilar, Remsima, Subcutaneous, Intravenous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In this study, CD (Crohn's disease) patients who achieved clinical response at week 30 after to Remsima (CT-P13, a biosimilar of infliximab) SC (subcutaneous formulation) will be randomly (1:1) assigned to intravenous infliximab (Remsima) group (Arm 2) or to continued infliximab (Remsima) SC group (Arm 3). The primary endpoint of the study is the non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate at week 54. Non-responder at week 30 will be allocated to Arm 1 (intravenous infliximab [Remsima] 10 mg/kg) and the secondary endpoint is the non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate at week 54. Through this study, the investigators aim to provide the clinical evidence for selecting the most optimal formulation of infliximab according to therapeutic response among Korean patients with CD.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-response to SC infliximab at week 30 and switched to infliximab IV 10 mg/kg every 8 weeks
Arm Type
Experimental
Arm Description
Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 1] Non-responders at week 30: Switched to infliximab IV 10 mg/kg every 8 weeks
Arm Title
Response to SC infliximab at week 30 and then, switched to infliximab IV 5 mg/kg every 8 weeks
Arm Type
Experimental
Arm Description
Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 2] Response to SC infliximab at week 30 and then, randomly allocated to infliximab IV 5 mg/kg every 8 weeks
Arm Title
Response to SC infliximab at week 30 and then, continued infliximab SC 120 mg every 2 weeks
Arm Type
Active Comparator
Arm Description
Patients with moderately to severely active Crohn's disease will be given IV (intravenous) infliximab 5 mg/kg at week 0 and 2. Then, they will be treated with SC (subcutaneous) infliximab every 2 weeks from week 6. At week 30. patients will be allocated to one of 3 arms according to their response to SC infliximab. [Arm 3] Response to SC infliximab at week 30 and then, randomly allocated to infliximab SC 120 mg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Infliximab-Dyyb
Other Intervention Name(s)
Infliximab
Intervention Description
Continued infliximab SC 120 mg every other week, if response to SC infliximab at week 30
Primary Outcome Measure Information:
Title
Deep remission rate of Arm 3 compared with Arm 2
Description
Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index) <150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation. CDAI can range from 0 to 600 and a higher value mean more clinically active disease. SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity. The non-inferiority of Arm 3 compared with Arm 2 will be test and the non-inferiority margin will be set as "-20%".
Time Frame
Week 54
Secondary Outcome Measure Information:
Title
Deep remission rate of Arm 3 compared with Arm 1
Description
Deep remission: all of these 3 criteria (1) CDAI (Crohn's disease activity index)<150, (2) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (3) No systemic corticosteroids use for at least 8 weeks before evaluation. CDAI can range from 0 to 600 and a higher value mean more clinically active disease. SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity. The non-inferiority of Arm 3 compared with Arm 1 will be test and the non-inferiority margin will be set as "-20%".
Time Frame
Week 54
Title
Corticosteroid-free endoscopic remission rate of each arm
Description
All of these 2 criteria should be met to be classified as a corticosteroid-free endoscopic remitter: (1) SES-CD (Simple Endoscopic Score for Crohn's disease) ≤2, (2) No systemic corticosteroids use for at least 8 weeks before evaluation SES-CD is scored for 5 segments (ileum, right colon, transverse colon, left colon, and rectum) for (1) ulcer size, (2) % of ulcerated surface, (3) % of affected surface, and (4) the presence of stenosis. A higher value means a high endoscopic disease activity.
Time Frame
Week 54
Title
Corticosteroid-free complete mucosal healing rate of each arm
Description
All of these 2 criteria should be met to be classified as an achiever of corticosteroid-free complete mucosal healing: (1) No visible ulcers (including aphthous ulcers) in ileocolonoscopy, (2) No systemic corticosteroids use for at least 8 weeks before evaluation
Time Frame
Week 54
Title
Corticosteroid-free clinical response (CDAI-70) rate of each arm
Description
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-70): (1) Reduction of CDAI (Crohn's disease activity index) 70 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Time Frame
Week 54
Title
Corticosteroid-free clinical response (CDAI-100) rate of each arm
Description
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical responder (CDAI-100): (1) Reduction of CDAI (Crohn's disease activity index) 100 or more compared with the baseline, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Time Frame
Week 54
Title
Corticosteroid-free clinical remission rate of each arm
Description
All of these 2 criteria should be met to be classified as a corticosteroid-free clinical remitter: (1) CDAI (Crohn's disease activity index) < 150, (2) No systemic corticosteroids use for at least 8 weeks before evaluation CDAI can range from 0 to 600 and a higher value mean more clinically active disease.
Time Frame
Week 54
Title
Corticosteroid-free biochemical remission rate of each arm
Description
All of these 2 criteria should be met to be classified as a biochemical remitter: (1) Both fecal calprotectin<250 µg/g and serum CRP (C-reactive protein) <0.5 mg/dL, (2) No systemic corticosteroids use for at least 8 weeks before evaluation
Time Frame
Week 54
Title
Rate of anti-drug antibody positivity in each arm
Description
Proportion of patients with a positive anti-infliximab antibody compared with the baseline
Time Frame
Week 54
Title
The proportion of patients with treatment-related adverse events
Description
Comparing the proportions of patients having any adverse events, serious adverse events, serious infections, and all types of adverse events as assessed by CTCAE v6.0
Time Frame
Week 54
Other Pre-specified Outcome Measures:
Title
Exploratory outcomes: trough level of infliximab to reach deep remission
Description
Trough level of infliximab at week 30 (before infliximab administration) to reach deep remission at week 54
Time Frame
Week 30
Title
Exploratory outcomes: trough level of infliximab to reach clinical remission
Description
Trough level of infliximab at week 30 (before infliximab administration) to reach clinical remission at week 54
Time Frame
Week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Moderate to severe Crohn's disease (Crohn's disease activity index 220 to 450) Ileocolonic Crohn's disease (CD) with Simple Endoscopic Score for Crohn Disease ≥6 or ileal or colonic CD with with Simple Endoscopic Score for Crohn Disease ≥4 and ulcer score ≥1 in at least one segment Fecal calprotectin ≥250 µg/g or C-reactive protein≥0.5 mg/dL Patients who have never been to exposed to any biologic agent Patients who are non-responsive or intolerance to conventional therapy (corticosteroids, immunomodulators, or antibiotics, etc.) or contraindicated to conventional therapy Patients who gave a voluntary informed consent Exclusion Criteria: Patients who have a history of hypersensitivity to humanized proteins Patients ever treated with corticosteroids within 8 weeks of screening date a) Symptomatic intestinal stricture, b) Symptomatic anal stricture, c) Untreated intra-abdominal abscess, d) Untreated perianal abscess, e) Abdominal surgery within 6 months, f) Patients who are expected to require intestinal surgeries during study period - However, the following patients can be included: from baseline, 4 weeks or more after proper drainage of perianal abscess and from baseline, 8 weeks or more after proper drainage of intra-abdominal abscess Active tuberculosis. However, the following patients can be included: Patients who were diagnosed with tuberculosis, but were properly treated with anti-tuberculosis therapy according to the standard guidelines and who were confirmed to be cured. Latent tuberculosis infection (LTBI): Patients confirmed as having latent tuberculosis through medical history, physical examination, chest X-ray, PPD (Purified Protein Derivative) skin test or interferon gamma release assay (IGRA) by a pulmonology specialist. However, patients with LTBI who finished proper treatment for LTBI for 4 weks and who are going to complete LTBI treatment. HBsAg (Hepatitis B virus surface antigen)-positivity. Patients with negative HBsAg, but positive IgG anti-HBc (Immunoglobulin G anti-Hepatitis B core antibody) should be tested for HBV (hepatitis B virus) DNA real time quantitative PCR (polymerase chain reaction). If HBV DNA real time quantitative PCR ≥10 IU/mL should be excluded. Anti-HCV (hepatitis C virus) antibody-positivity History of HIV (human immunodeficiency virus) infection of positivity for anti-HIV Heart disease of NYHA (New York Heart Association) Class III/IV Active infection Malignancy (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and uterine cervix cancer) or history of colonic or small bowel dysplasia within 5 years Pregnancy or lactating woman Patients who are not applying proper contraceptive measures and patients who do not have a plan for proper contraceptive measures for at least 6 months after the last dose of infliximab (oral, parenteral, or implantable hormonal contraceptives, diaphragm, condom, intra-uterine device, or abstinence are accepted as proper contraceptive methods. Patients who are decided to be not proper to be enrolled into the study by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byong Duk Ye, MD, PhD
Phone
82-2-3010-3181
Email
bdye@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byong Duk Ye, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30929895
Citation
Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.
Results Reference
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PubMed Identifier
33676969
Citation
Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.
Results Reference
background
PubMed Identifier
23856361
Citation
Colombel JF, Rutgeerts PJ, Sandborn WJ, Yang M, Camez A, Pollack PF, Thakkar RB, Robinson AM, Chen N, Mulani PM, Chao J. Adalimumab induces deep remission in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):414-22.e5. doi: 10.1016/j.cgh.2013.06.019. Epub 2013 Jul 12.
Results Reference
background

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Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD

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