None listed
Conditions
Interventions
1. FKB327 (Adalimumab) 40 mg/0.8mL, Solution for subcutaneous injection (Pre-filled syringe)
2. Humira (Adalimumab) 40mg/0.8mL, Solution for subcutaneaous injection (glass syringe)
Sponsors
Fujifilm kyowa Kirin Biologics Co., Ltd,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB327-002, with a minimum of 8 doses of study drug received, and are continuing with concomitant MTX and folate. 2. In the investigator’s opinion, the patient showed a clinical response to treatment during Study FKB327-002. 3. Are willing to participate in the study and have provided written informed consent. 4. Females of childbearing potential must have a negative pregnancy test prior to study dosing. Both sexes must be willing to take adequate contraceptive precautions throughout the study period and continuing for at least 5 months post study. Acceptable methods of contraception in this study are: surgical sterilisation, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, partner’s vasectomy, a double-protection method (condom or diaphragm with spermicide).
Exclusion criteria
Exclusion criteria: 1. Evidence of a serious adverse event (SAE) ongoing from Study FKB327-002 at entry to this study, including a serious infection, malignancy, or any other condition that may put patients at increased risk when receiving treatment with adalimumab. 2. Presence of active and/or untreated latent tuberculosis (TB) as detected by QuantiFERON test at Week 22 combined with chest X-ray at Week 24 in Study FKB327-002. Latent TB, treated with prophylactic anti-mycobacterial therapy for at least 3 weeks before study dosing is resumed, is acceptable. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in study FKB327-003 for this purpose. 3. Were non-compliant with FKB327-002 study procedures, or with any condition or circumstances, which, in the opinion of the Investigator, makes them unlikely or unable to comply with study procedures and requirements. 4. American College of Rheumatology (ACR) Functional Class IV. 5. Acute infection requiring antibiotic treatment within 2 weeks of Week 0 dosing. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in Study FKB327-003 in order to recover from infection requiring antibiotic treatment. 6. Presence of serious, uncontrolled disease of another body system including cardiovascular, neurological, pulmonary, renal and hepatic disease. 7. Presence of New York Heart Association (NYHA) Class III/IV heart failure. 8. Presence of any uncontrolled disease for which steroid treatment is regularly required for flares, eg, asthma. 9. Patients with demyelinating diseases (eg, multiple sclerosis). 10. Pregnant or breastfeeding women.
Countries
Belgium, Bulgaria, Canada, Chile, Czech Republic, Germany, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactElizabeth Rospigliosi
INVENTIV HEALTH CLINICAL PERU S.A
Outcome results
None listed