Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

Inclusion Criteria

•Subjects must have a diagnosis of Rheumatoid Arthritis (RA), fulfilling the new ACR/EULAR classification criteria 2010 with disease duration for at least 24 weeks.
•Active RA with a DAS28 of >3.2
•=3 swollen and/or tender joints of the hands
•Subjects must be DMARD-IR (inadequate responder)
•Must understand and voluntarily sign an informed consent form including written consent for data protection
•Must be able to adhere to the study visit schedule and other protocol requirements
•Must be aged = 18 years at time of consent
•Glucocorticoids treatment up to 10 mg prednisolon per day will be allowed at study entry
•At screening-visit patients should have been treated without alterations of DMARD therapy (for at least three months) (i.e. Methotrexate) (with or without concomitant use of steroids).
•Must be RF and/or ACPA positive
•= 3 swollen and/or tender joints of the hands
•At screening- visit patients should have been treated
without alterations of therapy for at least three months
with DMARDS (i.e. Methotrexate) with or without
concomitant use of steroids).
•Glucocorticoids treatment up to 10mg prednisolone per
day will be allowed at study entry.

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 156
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Individuals not able to understand and follow study protocol and not able to voluntarily sign informed consent
•Individuals not willing to follow study protocol and sign informed consent
•Individuals treated with biological or investigational products before.
•Individuals with claustrophobia, tattoos containing metal, magnetic endoprotheses, surgery on bone in between a time interval < 3 months, patients in any condition not allowing for MRI scan.
•Current treatment with MMF or preparations still in development.
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
•Any other autoimmune or inflammatory disease such as Psoriasis, SLE, PSS, MCTD, SpA, Behcet disease, vasculitis, autoimmune hepatitis or fibromyalgia
•Participation in another phase 1-4 treatment study for RA
•Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent
•Pregnant or lactating female (Women with child bearing potential have to use a highly effective contraceptive measure (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs) and continue its use for the time of exposure to the drug as required). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable
•Patients who possibly are dependent on the Principal Investigator or investigator
•Patients with serious or chronic infections within the previous 3 months
•Opportunistic infections within the 6 months before screening
•Cancer within the 5 years before screening (with the exception of treated and cured squamous or basal cell carcinoma of the skin)
•History of severe congestive heart failure
•Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal (a.e.diverticulitis), endocrine, pulmonary, cardiac, neurologic or cerebral disease
•Transplanted organ (with the exception of corneal transplantation done more than 3 months before screening)
•Evidence of active tuberculosis
•Evidence of chronic or active hepatitis B or C

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

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