RHEUMATOID ARTHRITIS MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. - At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. - Hs-CRP equal or greater than 8 mg/L. - Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose. 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 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: - Evidence of untreated or inadequately treated latent or active TB. - Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years. - History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug. - May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy). - Any second DMARD (Disease modifying anti-rheumatic drug) must be washed out prior to the first study dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the treatment efficacy between adalimumab-Pfizer and adalimumab-EU in subjects with moderately to severely active RA who are treated with adalimumab in combination with methotrexate.;Primary end point(s): Number of Participants With an American College of Rheumatology 20% (ACR20) Response; Timepoint(s) of evaluation of this end point: Week 12 ; Secondary Objective: - To evaluate the overall safety and tolerability of adalimumab-Pfizer and adalimumab-EU. - To evaluate the immunogenicity of adalimumab-Pfizer and adalimumab-EU. - To evaluate multiple composite and individual parameters of clinical response to adalimumab-Pfizer and adalimumab-EU. - To evaluate the overall safety, tolerability and immunogenicity of adalimumab-Pfizer after treatment transition from adalimumab-EU to adalimumab-Pfizer. - To evaluate the population pharmacokinetics (PK) of adalimumab-Pfizer and adalimumab-EU. - To evaluate the pharmacodynamic (PD) response to adalimumab-Pfizer and adalimumab-EU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of Participants With an American College of Rheumatology 20% (ACR20) Response - Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response - Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response - Disease Activity Score Based on 28-joints Count (DAS28)-4(CRP) - DAS Remission (=2.6) - EULAR Response - Change from baseline in individual components of ACR response - Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) - Serum drug concentration - Type, incidence, severity, timing, seriousness and relatedness of events (AEs) and laboratory abnormalities. ; Timepoint(s) of evaluation of this end point: Visit 1-18 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Hungary, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed