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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000337-13-DE

Enrollment

156

Registered

2013-02-12

Start date

2013-05-13

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Cimzia Product Name: Cimzia Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Current Sponsor code: UCB SA

Eligibility

Sex/Gender

All

Inclusion criteria

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 • = 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

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
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. Expected: • Group 1 (high voxel count treated with Certolizumab Pegol): 80%) • Group 2 (low voxel count treated with Certolizumab Pegol): 40%) • Group 3 (high or low voxel count treated with placebo): 20%.) ;Timepoint(s) of evaluation of this end point: End of Study	—

Measure

Time frame

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. Expected: • Group 1 (high voxel count treated with Certolizumab Pegol): 80%) • Group 2 (low voxel count treated with Certolizumab Pegol): 40%) • Group 3 (high or low voxel count treated with placebo): 20%.) ;Timepoint(s) of evaluation of this end point: End of Study

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of subjects in each treatment group reaching remission (defined as DAS28 < 2.6) after 1, 12 and 24 weeks • Proportion of subjects in each treatment group reaching low disease activity (defined as DAS 28 <3.2) after 24 weeks • Mean and median DAS28 after 1, 12 and 24 weeks • Proportion of subjects in each treatment group reaching HAQ of zero after 12 and 24 weeks • Mean and median HAQ after 1, 12 and 24 weeks • Mean and median SF-36 after 1, 12 and 24 weeks • Proportion of subjects in each treatment group with normal functional MRI after screening, week 12 and 24 weeks • Proportion of subjects in each treatment group with normal functional MRI after screening, 12 and 24 weeks • Mean and median ultrasound synovitis score after 1, 12 and 24 weeks • Mean and median ultrasound synovitis score after 1, 12 and 24 weeks • Mean and median area of BOLD signal after screening, week 12 and 24 weeks • Type, frequency, severity and relationship of adverse events, severe adverse events or suspected unexpected serious adverse reactions to drugs used in this study • Number of subjects who prematurely discontinue Certolizumab-Pegol due to any adverse event ;Timepoint(s) of evaluation of this end point: End of Study	—

Measure

Time frame

Secondary end point(s): • Proportion of subjects in each treatment group reaching remission (defined as DAS28 < 2.6) after 1, 12 and 24 weeks • Proportion of subjects in each treatment group reaching low disease activity (defined as DAS 28 <3.2) after 24 weeks • Mean and median DAS28 after 1, 12 and 24 weeks • Proportion of subjects in each treatment group reaching HAQ of zero after 12 and 24 weeks • Mean and median HAQ after 1, 12 and 24 weeks • Mean and median SF-36 after 1, 12 and 24 weeks • Proportion of subjects in each treatment group with normal functional MRI after screening, week 12 and 24 weeks • Proportion of subjects in each treatment group with normal functional MRI after screening, 12 and 24 weeks • Mean and median ultrasound synovitis score after 1, 12 and 24 weeks • Mean and median ultrasound synovitis score after 1, 12 and 24 weeks • Mean and median area of BOLD signal after screening, week 12 and 24 weeks • Type, frequency, severity and relationship of adverse events, severe adverse events or suspected unexpected serious adverse reactions to drugs used in this study • Number of subjects who prematurely discontinue Certolizumab-Pegol due to any adverse event ;Timepoint(s) of evaluation of this end point: End of Study

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Countries

Germany, Portugal, Serbia

Contacts

Public ContactClinical Trial Unit, Med. 3

Universitätsklinikum Erlangen

juergen.rech@uk-erlangen.de+4991318543014

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026