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)
- Conditions
- Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapyMedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-000337-13-DE
- Lead Sponsor
- niversitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
•Understands and voluntarily signs an informed consent
form
•Male or female, aged = 18 years at time of consent
•Must be able to adhere to the study visit schedule and
other protocol requirements
•Must satisfy the 2010 ACR/EULAR classification criteria
for rheumatoid arthritis plus a disease duration of at
least 6 months
•Must have active RA with a DAS28 =3.2
•= 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
•Individuals not able to understand and follow study
protocol and not able to voluntarily sign informed consent
•Individuals with claustrophobia, tattoos containing metal,
magnetic endoprostheses, surgery on bone in between a
time interval < 3 months.
•Patients treated before with any biological or small
molecule or medication under investigation for the
treatment of RA.
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary parameter of interest is the proportion of patients who reach low disease activity according to the DAS28 (DAS28 < 3.2) during the first 12 weeks of study participation according their baseline CNS activity measured by functional MRI.;Secondary Objective: To compare clinical responses to Certolizumab-Pegol in RA patients with high and low CNS activity in the functional MRI to placebo responses;Primary end point(s): Proportion of patients who reach low disease activity according to the DAS28 (DAS28 < 3.2) during the first 12 weeks of study participation according their screening CNS activity measured by functional MRI.<br>Expected:<br>•Group 1 (high voxel count treated with Certolizumab <br> Pegol): 80%)<br>•Group 2 (low voxel count treated with Certolizumab <br> Pegol): 40%)<br>•Group 3 (high or low voxel count treated with placebo): <br> 20%.)<br>;Timepoint(s) of evaluation of this end point: End of Study
- Secondary Outcome Measures
Name Time Method