Rheumatoid arthritis (RA) MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: CKD-506
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet assigned
CAS Number: 1637242-36-4
Current Sponsor code: C
Sponsors
Chong Kun Dang Pharmaceutical Corporation (CKD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Adult male or female aged between 18 and 65 years 2. 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. 3. Have active RA defined as meeting all criteria below: a. = 5 swollen joints (from a 66 swollen joint count [SJC]) and = 5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline, AND b. 28 joint count Disease Activity Score based on C-reactive protein (DAS28[CRP]) > 3.2 at Screening, AND c. Serum C-reactive protein (CRP) = upper limit of normal (ULN) at Screening. 4. Ongoing treatment with a stable dose of MTX as described below: a. 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. b. 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. 5. 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. 6. Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline 7. 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. 8. Able and willing to sign the informed consent as approved by the Institutional Review Boards (IRB)/Independent Ethics Committees (IEC). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Treatments for RA as follows: Alkylating agents at any time; JAK inhibitors at any time; Intravenous gamma globulin or plasmapheresis within 6 months prior to Baseline; Antimalarial or tetracycline therapy, use within 4 weeks prior to Baseline; Leflunomide use within 12 weeks prior to Baseline or in the case of cholestyramine washout, use within 4 weeks prior to Baseline; cyclosporine, other calcineurin inhibitors, gold therapy, sulfasalazine, mycophenolate, azathioprine, or other immunosuppressant drugs or conventional DMARDs within 8 weeks prior to Baseline; use of any currently licensed biologics with DMARD properties at any time. 2. 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. 3. Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Screening. 4. 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. 5. History of malignancy within the past 5 years prior to Screening. 6. History of or current myelo- or lymphoproliferative disorder. 7. History of demyelinating disease or current signs and symptoms suggestive of demyelinating disease, or immediate family history of demyelinating disease. 8. History of organ transplant. 9. History of tuberculosis (TB) infection. 10. Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus. 11. History of invasive or opportunistic infection or immunodeficiency syndrome. 12. Currently active infection or history of infection within the last 2 weeks of Screening or Baseline, treatment with injectable antibiotics in the 2 weeks prior to Screening or Baseline, treatment with any antivirals/antifungals in the 4 weeks prior to Screening or Baseline, history of herpes zoster or hospitalization for infection in the 6 months prior to Screening, history of recurrent infections prior to Screening, infected joint prosthesis at any time, with the prosthesis still in situ. 13. Administration of a live or attenuated vaccine within 4 weeks prior to Baseline 23. Participation in any investigational drug/device clinical study within 30 days or 5 half-lives prior to Screening, whichever is longer. 14. Lactating within 12 weeks prior to Baseline. 15. The results of the following laboratory tests performed at the central laboratory at Screening meet any of the criteria listed below: Hemoglobin <10g/dL ; White blood cells <3.0×103cells/mm3; Neutrophils <1.5×103cells/mm3; Lymphocytes <0.5×103 cells/mm3 ; Platelets <125×103cells/mm3; Alanine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 1) To evaluate the effects of CKD-506 on physical function 2) To evaluate the effects of CKD-506 on quality of life 3) To evaluate the safety and tolerability of CKD-506 ;Primary end point(s): Change from baseline in DAS28(CRP);Timepoint(s) of evaluation of this end point: Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at Weeks 2, 4, 8, and 12. ; Secondary end point(s): Efficacy: 1) ACR20 response rate at week 2,4,8 and 12 2) Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8 3) ACR50 response rate at week 2,4,8 and 12 4) ACR70 response rate at week 2,4,8 and 12 5) Change from baseline in ACRn at week 2, 4, 8 and 12 6) Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12 7) Change from Baseline in the duration of morning stiffness at Weeks 2, 4, 8, and 12 8) Change from Baseline in the Short Form-36 item Health Survey (SF- 36) at Weeks 4 and 12 9) Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12 10) Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12 11) The proportion of subjects achieving Low Disease Activity (LDA) at week 2,4,8 and 12 12) The proportion of subjects achieving Clinical Remission at week 2,4,8 and 12 13) Change from baseline in HAQ-DI qt week 2,4,8 and 12 Safety and Tolerability: The number of subjects with adverse events, abnormal lab tests, vital sign and ECG. | — |
Countries
Czech Republic, Georgia, Poland, Russian Federation, Ukraine
Contacts
Public ContactClinical Trials information
Chong Kun Dang Pharmaceutical Corporation (CKD)
Outcome results
None listed