Status:
COMPLETED
Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
By using functional MRI the investigators have recently shown that TNFi elicit rapid changes in brain function linked to the perception of RA \[5\]. Functional MRI represents a method allowing detecti...
Detailed Description
Randomized double-blinded controlled multi-centre, study over 12 weeks, followed by a 12 weeks single blinded multicenter trial in 156 patients with RA with inadequate response to DMARD therapy. The s...
Eligibility Criteria
Inclusion
- 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
- 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.
- .
Exclusion
- 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 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01864265
Start Date
July 1 2013
End Date
January 10 2020
Last Update
March 10 2020
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité - Universitätsmedizin Berlin; Campus Charité Mitte Klinik für Rheumatologie und klinische Immunologie Studienambulanz
Berlin, Germany, 10117
2
University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology
Erlangen, Germany, 91054
3
Medizinische Universitätsklinik Freiburg Abteilung Rheumatologie und Klinische Immunologie
Freiburg im Breisgau, Germany, 79106
4
Universitätsklinikum Leipzig AÖR Department Innere Medizin Sektion Rheumatologie
Leipzig, Germany, 04103