A STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR
- Conditions
- Psoriatic arthritis (PsA)MedDRA version: 18.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-001368-46-BE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 390
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. The subject has signs and symptoms consistent with the diagnosis of PsA for at least 6 months and fulfills CASPAR (ClASsification criteria for Psoriatic ARthritis) Criteria and has evidence of active arthritis based upon having both =3 tender/painful joints and = 3 swollen joints at screening and baseline.
2. Ongoing treatment with a stable dose of a traditional non-biologic DMARD (eg, methotrexate, sulfasalazine or leflunomide) (Background DMARDs, as per protocol).
3.The subject has signs and symptoms consistent with the diagnosis of PsA for at least 6 months and fulfills CASPAR Criteria at screening and has evidence of active arthritis based upon number of tender/painful and swollen joints.
4. PsA Patient Population
• Subjects must have received at least one approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective and/or not tolerated as follows:
An inadequate response to TNF inhibitor treatment due to lack of efficacy as evident by active PsA at screening, as defined above, and prior treatment according to local label and after minimum treatment duration based upon the agent received:
• At least 3 months of adalimumab treatment.
• At least 3 months of etanercept treatment.
• At least 4 infusions of infliximab.
• At least 3 injections of golimumab.
• At least 3 months of certoluzimab.
An inadequate response to TNF inhibitor treatment due to intolerance is defined as a treatment-related adverse event (eg, infusion/injection reactions, infections, laboratory test
changes, etc).
5. Subject has discontinued all disallowed concomitant medications for the required time prior to the first dose of study medication and is taking only those concomitant medications in doses and frequency allowed by the protocol.
Subjects who are receiving any investigational or marketed treatment for PsA or psoriasis not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half lives, whichever is longer. All biologic agents not
otherwise mentioned (eg, exclusion criteria #16) must be discontinued for a minimum of 6 months prior to the first dose of study drug.
6. Subjects must not be receiving TNF inhibitors. Subjects on TNF inhibitors must discontinue according to the following criteria:
• Etanercept (Enbrel®): Discontinued at least 4 weeks prior to the first dose of study drug;
• Adalimumab (Humira®): Discontinued at least 10 weeks prior to first dose of study drug;
• Infliximab (Remicade®): Discontinued at least 8 weeks prior to the first dose of study drug;
• Golimumab (Simponi®): Discontinued at least 10 weeks prior to the first dose of study drug.
• Certoluzimab (Cimzia®): Discontinued at least 10 weeks prior to first dose of study drug.
7. Meet all other eligibility criteria described in the PsA Patient Population, as per Protocol and the Other Inclusion Criteria, as per protocol.
Please see the Protocol for the full list of inclusion criteria.
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 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Subjects presenting with any of the following will not be included in the study:
1. Currently have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis, which is allowed.
2. Pregnant females, breastfeeding females, females of child-bearing potential who are not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study. (Further description of the requirements and a list of contraceptives considered highly effective and acceptable for use in this study will be found in the Contraceptive Methods in Women of Childbearing Potential section of the protocol).
3. Blood dyscrasias within 3 months prior to the first dose of study drug including confirmed:
a. Hemoglobin <10 g/dL (<100 g/L);
b. White blood cell count <3.0 x 10x9/L (<3000 mm3);
c. Absolute neutrophil count =1.5 x 10x9/L (<1500 mm3);
d. Absolute lymphocyte count of <1.0 x 10x9/L (<1000/mm3);
e. Platelet count <100 x 10x9/L (<100,000/mm3).
4. Estimated Creatinine Clearance <40 ml/min based on Cockcroft Gault equation (Appendix 2).
5. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit.
6. Current or recent history of uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.
7. History of any autoimmune rheumatic disease other than PsA (including systemic lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or known diagnosis of fibromyalgia, without approval by Sponsor. Also excluded are subjects with prior history of, or current, rheumatic inflammatory disease other than PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by Sponsor.
8. A subject with known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
9. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
10. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
11. History of active infection (including localized infection):
• Requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication;
• Requiring oral antimicrobial therapy within 2 weeks prior to the first dose of study medication.
12. Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication. (See Vaccine Guidelines for further information regarding avoidance of household contacts who may be vaccinated, as per protocol).
13. A subject with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method