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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04204603
Other study ID # 182RA18009
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 30, 2018
Est. completion date October 29, 2019

Study information

Verified date December 2019
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date October 29, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosis of RA for at least 6 months prior to Screening, currently meet the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA, and are ACR functional class I-III.

- Have active RA

- Ongoing treatment with a stable dose of MTX as described below:

1. Use of oral or injectable MTX on a continuous basis for at least 12 weeks prior to Baseline and on a stable dose and route of administration between 15 mg and 25 mg/weekly for at least 8 weeks prior to Baseline and planned during the study.

2. Subjects should be on an adequate and stable dose of folic acid for at least 4 weeks prior to first administration of study treatment and planned during the study.

- Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study treatment.

- Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline

- Sexually active men, if not surgically sterile, must agree to use a medically acceptable form of contraception during the study and continue its use for at least 12 weeks after the last dose of study treatment.

Exclusion Criteria:

- Treatments for RA as follows: JAK inhibitors at any time; use of any currently licensed biologics with DMARD properties at any time.

- Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that has not been stable for at least 4 weeks prior to Screening.

- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose or route of administration for at least 2 weeks prior to Baseline and planned during the study.

- History of tuberculosis (TB) infection.

- Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus.

- Currently active infection or history of infection within the last 2 weeks of Screening or Baseline

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CKD-506
Tablets for oral administration
Placebo
Tablets for oral administration

Locations

Country Name City State
Czechia 182RA18009 Stie# CZ06 Broumov
Czechia 182RA18009 Stie# CZ03 Olomouc
Czechia 182RA18009 Stie# CZ02 Praha
Czechia 182RA18009 Stie# CZ05 Praha
Czechia 182RA18009 Stie# CZ07 Praha
Czechia 182RA18009 Stie# CZ08 Praha
Czechia 182RA18009 Stie# CZ09 Praha
Czechia 182RA18009 Stie# CZ01 Uherské Hradište
Georgia 182RA18009 Stie# UA03 Lviv
Georgia 182RA18009 Stie# GE01 Tbilisi
Georgia 182RA18009 Stie# GE02 Tbilisi
Georgia 182RA18009 Stie# GE03 Tbilisi
Poland 182RA18009 Stie# PL04 Bydgoszcz
Poland 182RA18009 Site# PL01 Elblag
Poland 182RA18009 Stie# PL03 Grodzisk Mazowiecki
Poland 182RA18009 Stie# PL02 Katowice
Poland 182RA18009 Stie# PL07 Lódz
Poland 182RA18009 Stie# PL06 Poznan
Poland 182RA18009 Stie# PL08 Poznan
Poland 182RA18009 Stie# PL05 Skierniewice
Poland 182RA18009 Stie# PL10 Torun
Poland 182RA18009 Stie# PL09 Warszawa
Russian Federation 182RA18009 Stie# RF05 Moscow
Russian Federation 182RA18009 Stie# RF10 Moscow
Russian Federation 182RA18009 Stie# RF09 Perm
Russian Federation 182RA18009 Stie# RF03 Saint Petersburg
Russian Federation 182RA18009 Stie# RF08 Saint Petersburg
Russian Federation 182RA18009 Stie# RF02 Togliatti
Russian Federation 182RA18009 Stie# RF07 Tver
Russian Federation 182RA18009 Stie# RF06 Vladimir
Ukraine 182RA18009 Stie# UA10 Ivano-Frankivs'k
Ukraine 182RA18009 Stie# UA09 Kharkiv
Ukraine 182RA18009 Stie# UA01 Kyiv
Ukraine 182RA18009 Stie# UA04 Kyiv
Ukraine 182RA18009 Stie# UA07 Kyiv
Ukraine 182RA18009 Stie# UA11 Kyiv
Ukraine 182RA18009 Stie# UA05 Vinnytsia
Ukraine 182RA18009 Stie# UA06 Vinnytsia

Sponsors (1)

Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Countries where clinical trial is conducted

Czechia,  Georgia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in DAS28(CRP) at week 12 Baseline and week 12
Secondary Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12 At weeks 2, 4, 8 and 12
Secondary Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8 Baseline and up to week 8
Secondary Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12 At weeks 2, 4, 8 and 12
Secondary Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12 At weeks 2, 4, 8 and 12
Secondary Change from Baseline in ACRn at Weeks 2, 4, 8, and 12 Baseline and up to week 12
Secondary Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12 Baseline and weeks 4, 12
Secondary Change from Baseline in the duration of morning stiffness (in minutes and in severity as measured with a visual analog scale [VAS]) at Weeks 2, 4, 8, and 12 Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness). Baseline and up to week 12
Secondary Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12 The Short Form-36 item Health Survey (SF-36) consists of eight scaled scores; physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. which are the weighted sums of the questions in their section. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. Baseline and weeks 4, 12
Secondary Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12 Baseline and up to week 12
Secondary Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12 Baseline and up to week 12
Secondary Response to treatment based on the achievement of Low Disease Activity (LDA) status based on each of the following definitions at Weeks 2, 4, 8,and 12: DAS28(CRP) = 3.2, SDAI = 11.0, CDAI = 10.0 at Weeks 2, 4, 8, and 12 At weeks 2, 4, 8 and 12
Secondary Response to treatment based on the achievement of remission based on each of the following definitions at Weeks 2, 4, 8, and 12: DAS28(CRP) < 2.6, Boolean parameters, SDAI = 3.3, CDAI = 2.8 at Weeks 2, 4, 8, and 12 At weeks 2, 4, 8 and 12
Secondary Improvement of physical ability defined as change from Baseline in HAQ-DI = 0.22 at Weeks 2, 4, 8, and 12 Baseline and up to week 12
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