Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.
- Conditions
- Early active rheumatoid arthritisMedDRA version: 17.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-001729-25-DE
- Lead Sponsor
- CB Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. An IRB/ IEC approved written Informed Consent form is signed and dated by the subject prior to any study procedure.
2. This criterion is only applicable for the sub-study and does not impact the eligibility of the subject for the main study: to allow collection of blood samples for the genomic, genetic and proteomic analysis the subjects must have signed and dated an IRB/ IEC approved written Pharmacogenomics Informed Consent form.
3. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
4. Subject is male or female and must be at least 18 years old at the Screening Visit.
5. 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/implantable hormonal contraceptives, intrauterine device or barrier method and spermicide) at Screening. Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for at least 3 months (United States/Canada) or 6 months (Europe, Australia and Latin-America) after the last dose of study treatment. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 3 months (United States/Canada) or 6 months (Europe, Australia and Latin-America) after the subject receives their last dose of study treatment.
6. Subjects must have a time since diagnosis of adult-onset RA less than 1 year as defined by the 2010 ACR / EULAR classification criteria from Screening Visit.
7. Subjects must be DMARD-naïve at Screening and Baseline (except antimalarials, see Section 6.2.2 of the protocol).
8. Subjects must have a positive RF or positive ACPA result at Screening.
9. Subjects must have active RA disease as defined in the study protocol.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 6 months following last dose of study drug.
2. The subject has previously participated in this study and has received CZP treatment, or has previously received CZP in or outside of another clinical study.
3. The subject 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.
4. The subject has a known hypersensitivity to any components of CZP or with a history of an adverse reaction to polyethylene glycol (PEG).
5. Subjects must not have a secondary, noninflammatory type of musculoskeletal 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 RA.
6. Subjects must not have a diagnosis of any other inflammatory arthritis nor have a Steinbrocker IV functional capacity.
7. Subjects must not have received any experimental nonbiological therapy in the 3 past months or within 5 half-lives prior to Baseline (whichever is longer).
8. Subjects must not have received any experimental or approved biological agent prior to Baseline.
9. Subjects must not have used indicated medications in table 6.1 of the Protocol.
10. Concurrent malignancy or a history of malignancy.
11. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
12. Subjects with a history of blood dyscrasias.
13. Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease or other significant immunological/inflammatory disease including systemic lupus erythematosus, inflammatory bowel disease.
14. Subjects with congestive heart failure as defined by the New York Heart Association 1994 classification criteria.
15. Subjects with a history of, or suspected, demyelinating disease of the central nervous system.
16. Subjects with any other condition which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.
17. Subject with a value >1.5x ULN for any of the following liver function tests (LFTs) at Screening: •Aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase [GOT]); • Alanine aminotransferase (ALT) (glutamate-pyruvate transaminase [GPT]).
18. Subject has history of chronic alcohol or drug abuse within the last 1 year.
19. Subject 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.
20. Subjects with history of or current clinically active infection (including infections verified by chest X-ray) with histoplasma, coccidiodes, paracoccidioides, pneumocystis, nontuberculous mycobacteria, blastomyces, or aspergillus.
21. Subjects with a history of chronic or recurrent infections (>3 episodes requiring antibiotics or 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.
22. Subje
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