Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
UCB Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must be at least 18 years old at the screening visit. 2. Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (i.e. either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol. 3. Patients must have a diagnosis of adult–onset RA (of at least six months duration but not longer than ten years) as defined by the 1987 American College of Rheumatology classification criteria. 4. Patients must have moderate to low disease activity as defined by all of the following: • CDAI > 6 and = 16 at Screening and Baseline • = 2 tender joints (28 joint count) at Screening and Baseline • = 2 swollen joints (28 joint count) at Screening and Baseline • fulfilling 1 of the following 2 criteria during the screening period: • =28 mm/hour ESR (Westergren), or • CRP >10 mg/L 5. Patients must have received combination or mono DMARD therapy ((i.e., Sulfasalazine = 3mg/day; Leflunomide = 20mg/day; Hydroxychloroquine =400mg/day; MTX = 25mg/week) for at least six months prior to the Baseline visit. The dose and route of administration of the DMARD therapy must have been stable for at least 2 months prior to the baseline visit. 6. Patients must be able to understand the information provided to them and to give written Informed Consent. 7. Patients 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. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis,ankylosing spondylitis or connective tissue disease). 2. Patients 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 patient’s primary diagnosis of RA. 3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 4. Patients must be free of prohibited medication as detailed in the respective table in the protocol. 5. Patients must not have received any previous biological therapy for RA. 6. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit. 7. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug. 8. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection. 9. Patients with active TB (or history of active TB) or positive chest X–ray for TB or positive (defined as induration of = 5mm) PPD skin test or patients having close contact with an individual with active TB. Patients having a PPD skin test greater or equal to 5 mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent tuberculosis (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of certolizumab pegol. 10. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound). 11. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time. 12. Patients with known concurrent acute or chronic viral hepatitis B or C. 13. Patients with known human immunodeficiency virus (HIV) infection. 14. Patients receiving any vaccination (live or attenuated) within eight weeks prior to Baseline. (However, influenza and pneumococcal vaccines are allowed) 15. 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). 16. Patients with a history of blood dyscrasias. 17. Patients 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. 18. Patients with class III or IV congestive heart failure. New York Heart Association (NYHA) 1964. 19. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis). 20. Patients with a history of an adverse reaction to PEG or a protein medicinal product. 21. Patients with any other condition (i.e. clinically significant laboratory values) which in the Investigator’s judgment would make the patient u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of certolizumab pegol as an add-on therapy in demonstrating clinical remission at both Week 20 and Week 24 (defined as Clinical Disease Activity Index [CDAI] of = 2.8).;Primary end point(s): The primary efficacy variable is the proportion of subjects in CDAI remission (CDAI = 2.8) at both Week 20 and Week 24 visits.;Secondary Objective: To compare the efficacy of the two treatment arms in: - Achievement of clinical remission at both Week 20 and Week 24. - Maintenance of remission between Week 24 and Week 52. - Reduction of signs and symptoms of the disease at Week 24 as measured by ACR criteria. - Improvement in patient’s physical function as measured by the HAQ-DI at Weeks 24. - Improvement in patient’s Health-Related Quality of Life as measured by the SF-36 Physical and Mental Component Summary scores (PCS and MCS, respectively) and SF-36 domains at Weeks 24. - Relief in patient's pain, fatigue and disease activity as measured by Patient’s Assessment of Arthritis Pain-VAS, Fatigue Assessment scale and Patient’s Global Assessment of Disease Activity -VAS at Week 24. - To evaluate the tolerability and safety of certolizumab pegol therapy. | — |
Countries
Austria, France, Germany, Italy, Poland
Outcome results
None listed