Psoriatic arthritis MedDRA version: 9.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis
Conditions
Sponsors
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be at least 18 years old at the Screening Visit. 2. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the subject or designee/witness. 3. Subject is considered reliable, willing, and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the Investigator. 4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral, parenteral, or implantable hormonal contraceptives, intrauterine device or barrier, or spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for at least 10 weeks (or longer as per local requirement) after the last dose of study treatment. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for at least 10 weeks (or longer as per local requirement) after the subject receives their last dose of study treatment. 5. Subject must have a diagnosis of adult onset PsA of at least 6 months’ duration as defined by the CASPAR criteria (see Appendix 17.1). 6. Subject must have active psoriatic skin lesions or a documented history of PSO. 7. Subject must have active arthritis as defined in the protocol. 8. Subjects must have failed 1 or more disease modifying antirheumatic drug (DMARDs). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject: 1. has previously participated in this study or has previously received CZP treatment in or outside of another clinical study. 2. has participated in another study of a medication or a medical device under investigation within the last 3 months or is currently participating in another study of a medication or medical device under investigation. 3. has history of chronic alcohol abuse or drug abuse within the last year. 4. has any medical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject’s ability to participate in this study. 5. has a known hypersensitivity to any components of CZP, placebo or with a history of an adverse reaction to polyethylene glycol (PEG). 6. must not have a diagnosis of any other inflammatory arthritis. 7. must not have a secondary, noninflammatory condition that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject’s primary diagnosis of PsA. 8. must not have used medications in the manner as detailed by the exclusion criteria in the protocol. 9. must not have received any nonbiological therapy for PsA not listed in section "Prior medications exclusion" of the protocol within or outside a clinical study in the 3 months or within 5 half lives prior to Baseline (whichever is longer). 10. must not have received experimental biological agents other than those listed in Table 6:1 and Table 6:2 of the protocol. 11. must not have received previous treatment with a PEGylated compound that resulted in a severe hypersensitivity reaction or an anaphylactic reaction. 12. may not have been exposed to more than 1 TNF antagonist prior to the Baseline Visit and may not be a primary failure to any TNF antagonist therapy (as defined in the protocol). 13. may not have been exposed to more than 2 previous biological response modifiers for PsA or PSO. 14. Female who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following the last dose of investigational product. 15. with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster), hospitalization for any infection in the last 6 months, or any current sign or symptom that may indicate an infection. 16. with known TB disease, high risk of acquiring TB infection, or latent TB infection, as defined in the protocol. 17. with concurrent acute or chronic viral hepatitis B or C or with known human immunodeficiency virus infection (HIV). 18. with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus. 19. with a history of an infected joint prosthesis at any time with that prosthesis still in situ. 20. receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline. 21. with a high risk of infection in the Investigator’s opinion. 22. with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease. 23. with concurrent malignancy or a history of malignancy (subjects with less than 3 excised basal cell carcinomas or with cervical carcinoma in situ successfully surgically treated more than 5 years prior to S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to demonstrate the efficacy of CZP administered sc at the dose of 200mg every 2 weeks or 400mg every 4 weeks after loading with 400mg at Weeks 0, 2, and 4 on the signs and symptoms of active PsA and on the inhibition of progression of structural damage in adults with active PsA.;Secondary Objective: The secondary objectives of the study are to assess the effects on safety and tolerability and to demonstrate the effects of CZP on: • Health outcomes • Psoriatic skin disease in the subgroup of affected subjects (>3% BSA) at Baseline • Dactylitis • Enthesitis • Axial involvement in subgroup of affected subjects (BASDAI =4) at Baseline;Primary end point(s): Primary efficacy variables: - the ACR20 response at Week 12 - the change from Baseline in mTSS at Week 24 Pharmacokinetic and pharmacodynamic variables: - Certolizumab pegol plasma concentrations at periods defined in the protocol. - Anti-certolizumab pegol antibodies at periods defined in the protocol. - Dickkopf-related protein 1 (DKK1) and sclerostin levels may be analyzed for exploratory biomarker research using selected samples collected for measurement of CZP plasma concentration. Safety variables: - adverse events - serious adverse events, - vital signs, - physical examination - signs and symptoms of latent or active tuberculosis - measurements of laboratory parameters (hematology, biochemistry and urinalysis) - pregnancy testing | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed