A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Brief summary

This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis

Detailed description

CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Daniel E. Furst, Janusz Jaworski, Rafał Wojciechowski, Piotr Wiland, Anna Dudek et al. (19 authors)

Lara D. Veeken2021-05-2118 citations

10.1093/rheumatology/keab460

Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study.

Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E.

2021-02-0520 citations

10.1186/s13075-020-02394-7

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

Kyung‐Sang Yu, In‐Jin Jang, Hyeong‐Seok Lim, Jang Hee Hong, Min‐Gul Kim et al. (20 authors)

Clinical and Translational Science2021-01-2716 citations

10.1111/cts.12967

Interventions

BIOLOGICALCT-P17 SC

Subcutaneous injection of Adalimumab 40mg every two weeks

BIOLOGICALHumira SC

Subcutaneous injection of Adalimumab 40mg every two weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Patient is male or female aged 18 to 75 years old, both inclusive. * Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .

Exclusion criteria

* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes. * Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Design outcomes

Primary

Measure	Time frame	Description
American College of Rheumatology(ACR)20 Response Rate at Week 24.	Week 24	ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)

Secondary

Measure	Time frame	Description
ACR50 and ACR70 Response Rate at Week 24	Week 24	ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
ACR20, ACR50, and ACR70 Response Rate up to Week 52	Up to Week 52	ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)	Week 24	The Disease activity score (DAS28) (c-reactive protein \[CRP\]) score was derived using the following formulae: DAS28 (CRP) = 0.56\√(TJC28) + 0.28\√(SJC28) + 0.014\(GH) + 0.36\ln(CRP+1) + 0.96 Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100). DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.

Countries

Bulgaria

Participant flow

Participants by arm

Arm	Count
CT-P17 Patients were administered CT-P17 (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.	324
EU-approved Humira Patients were administered EU-approved Humira (40mg/0.4mL) by SC injection via PFS EOW in combination with MTX and folic acid from Week 0 to Week 24.	324
Total	648

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Treatment Period II (Week 26 to Week 52)	Adverse Event	3	3	6
Treatment Period II (Week 26 to Week 52)	Could not visit the site due to COVID-19 pandemic	2	1	0
Treatment Period II (Week 26 to Week 52)	Lost to Follow-up	0	0	1
Treatment Period II (Week 26 to Week 52)	Physician Decision	1	0	0
Treatment Period II (Week 26 to Week 52)	Significant dose delay	1	0	0
Treatment Period II (Week 26 to Week 52)	Withdrawal by Subject	9	2	2
Treatment Period I (Week 0 to Week 26)	Adverse Event	7	8	0
Treatment Period I (Week 0 to Week 26)	Lost to Follow-up	2	0	0
Treatment Period I (Week 0 to Week 26)	Patient decision	0	2	0
Treatment Period I (Week 0 to Week 26)	Physician Decision	1	0	0
Treatment Period I (Week 0 to Week 26)	Protocol Violation	1	1	0
Treatment Period I (Week 0 to Week 26)	Significant dose delay	1	0	0
Treatment Period I (Week 0 to Week 26)	Withdrawal by Subject	9	8	0

Baseline characteristics

Characteristic	Total	CT-P17	EU-approved Humira
Age, Categorical <=18 years	1 Participants	1 Participants	0 Participants
Age, Categorical >=65 years	97 Participants	55 Participants	42 Participants
Age, Categorical Between 18 and 65 years	550 Participants	268 Participants	282 Participants
Age, Continuous	54.0 years	53.5 years	54.0 years
Race/Ethnicity, Customized Race Other	51 Participants	25 Participants	26 Participants
Race/Ethnicity, Customized Race White	597 Participants	299 Participants	298 Participants
Region of Enrollment Bulgaria	39 Participants	20 Participants	19 Participants
Region of Enrollment Hungary	34 Participants	17 Participants	17 Participants
Region of Enrollment Lithuania	9 Participants	4 Participants	5 Participants
Region of Enrollment Peru	51 Participants	25 Participants	26 Participants
Region of Enrollment Poland	462 Participants	231 Participants	231 Participants
Region of Enrollment Ukraine	53 Participants	27 Participants	26 Participants
Sex: Female, Male Female	514 Participants	249 Participants	265 Participants
Sex: Female, Male Male	134 Participants	75 Participants	59 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 324	0 / 324	0 / 303	0 / 152	0 / 152
other Total, other adverse events	96 / 324	118 / 324	50 / 303	35 / 152	33 / 152
serious Total, serious adverse events	12 / 324	19 / 324	6 / 303	3 / 152	5 / 152

Outcome results

Primary

American College of Rheumatology(ACR)20 Response Rate at Week 24.

ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)

Time frame: Week 24