Rheumatoid Arthritis Clinical Trial
— PreCePRAOfficial title:
Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain. A Multi-center, Randomized Double-blind Controlled Study Prediction of Response to Certolizumab-Pegol in RA (PreCePRA)
NCT number | NCT01864265 |
Other study ID # | PreCePRA |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | January 10, 2020 |
Verified date | March 2020 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 detecting tiny changes in neuronal activity by measuring alterations of blood flow in the context of neuronal activation. TNFi rapidly reversed the widespread activation of brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well as those involved in the control, of mood and emotions such as the limbic system. Moreover, as small phase I study with 10 patients with RA showed that high brain activity detected in the functional MRI predicts clinical response to Certolizumab Pegol after 1 month, suggesting the central nervous system activity may be used as a tool to predict response to TNFi [8]. The rationale of this study is to test whether response to TNFi can be predicted by using functional MRI.
Status | Completed |
Enrollment | 156 |
Est. completion date | January 10, 2020 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 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 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin; Campus Charité Mitte Klinik für Rheumatologie und klinische Immunologie Studienambulanz | Berlin | |
Germany | University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology | Erlangen | |
Germany | Medizinische Universitätsklinik Freiburg Abteilung Rheumatologie und Klinische Immunologie | Freiburg | |
Germany | Universitätsklinikum Leipzig AÖR Department Innere Medizin Sektion Rheumatologie | Leipzig | |
Portugal | Hospitais da Universidade (SRHUC) Reumatologia | Coimbra | |
Serbia | Belgrade University School of Medicine Director of the Institute Institute of Rheumatology | Belgrad |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany, Portugal, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reaching low disease activity | 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. | 6 months | |
Secondary | Remission | Proportion of subjects in each treatment group reaching remission (defined as DAS28 < 2.6) after 1, 12 and 24 weeks | 6 months | |
Secondary | Quality of Life | HAQ of zero after 12 and 24 weeks to baseline | 6 months | |
Secondary | SF36 | Mean and median SF-36 after 1, 12 and 24 weeks | 6 months | |
Secondary | MRI | Proportion of subjects in each treatment group with normal functional MRI after screening, week 12 and 24 weeks | 6 months | |
Secondary | Normal fMRI | Proportion of subjects in each treatment group with normal functional MRI after screening, 12 and 24 weeks | 6 months | |
Secondary | Ultrasound score | Mean and median ultrasound synovitis score after 1, 12 and 24 weeks | 6 months | |
Secondary | Bold signal | Mean and median ultrasound synovitis score after 1, 12 and 24 weeks | 6 months | |
Secondary | Adverse events | Type, frequency, severity and relationship of adverse events, serious adverse events or suspected unexpected serious adverse reactions to drugs used in this study | 6 months | |
Secondary | Number of patients who discontinue Certolizumab-Pegol | Number of subjects who prematurely discontinue Certolizumab-Pegol due to any adverse event | 6 months |
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