Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Other des
Sponsors
UCB Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have either failed to achieve remission in study C87076 at Week 20 and/or Week 24 (CDAI > 2.8), which is confirmed at Week 24 or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52. 2. Subjects must have complied with the protocol requirements during their participation in study C87076. 3. Female subjects of childbearing potential must have a negative urine pregnancy test at the Entry visit and must continue to have negative urine pregnancy tests administered every 8 weeks immediately before certolizumab pegol administration. Female subjects must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral / parenteral / implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol. 4. Subjects must be able to understand the information provided to them and to give written Informed Consent for C87080. 5. Subjects must be able and willing to comply with the requirements of 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or connective tissue disease) 2. Subjects must not have a secondary, non–inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) 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. 3. Subjects must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 4. Female subjects who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug. 5. Subjects with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection during C87076 participation (including herpes zoster), or any current sign or symptom that may indicate an infection. 6. Subjects with active tuberculosis. 7. Subjects at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and subjects who are permanently bed ridden or wheelchair bound) 8. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time 9. Subjects with known concurrent acute or chronic viral hepatitis B or C. 10. Subjects with known human immunodeficiency virus (HIV) infection 11. Subjects receiving any vaccination (live or attenuated) during their participation in C87076 study (however, influenza and pneumococcal vaccines are allowed). 12. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening). 13. Subjects with a history of blood dyscrasias 14. 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 15. Subjects with class III or IV congestive heart failure. New York Heart Association (NYHA) 1964. 16. Subjects with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis). 17. Subjects with a history of an adverse reaction to PEG or a protein medicinal product. 18. Subjects with any other condition (e.g. clinically significant laboratory values) which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Continue to assess the safety of certolizumab pegol in combination with Disease Modifying Anti–Rheumatic Drug (DMARD)-treatment.;Secondary Objective: Assess throughout the entire treatment period: - Proportion of subjects in clinical remission defined as: - 28-joint count Disease Activity Score - Clinical Disease Activity Index - Simplified Disease Activity Index - Reduction of signs and symptoms of the disease - Improvement in subject’s physical function - Relief in subject's pain, fatigue and disease activity - To assess the pharmacokinetic profile and immunogenicity of certolizumab pegol in combination with DMARD(s). Assess at specific time points during the treatment period: - To explore, at Week 0, subjects’ willingness to self-inject certolizumab pegol at home - For subjects choosing to self-inject certolizumab pegol, to explore the subjects’ experience with self-injection (including injection site reactions) - For subjects not self-injecting certolizumab pegol, to explore the burden of injection site reactions ;Primary end point(s): Efficacy variables to be assessed are: - Proportion of subjects in clinical remission defined as per protocol: - ACR 20 (American College of Rheumatology 20% response rate), ACR 50 and ACR70 responder rate - Change from Baseline in HAQ–DI. - Change from Baseline in Subject's Assessment of Arthritis Pain-VAS, Fatigue Assessment scale and Subject's Global Assessment of Disease Activity-VAS. - Subjects willingness to self-inject (yes/no) - For subjects choosing to self-inject, SIAQ PRE-Self-injection scores and SIAQ POST self-injection scores - For subjects not self-injecting, ISRQ score. Pharmacokinetic and Pharmacodynamic variables to be assessed are: - Plasma samples for the measurement of certolizumab pegol concentrations and anti- certolizumab pegol antibodies will be collected Safety variables to be assessed are: - Frequency, severity, nature, relationship and durati | — |
Countries
Austria, France, Germany, Italy, Poland
Outcome results
None listed