Polyarthritis MedDRA version: 9.1 Level: LLT Classification code 10046107 Term: Unspecified polyarthropathy or polyarthritis involving pelvic region and thigh
Conditions
Sponsors
Dekan des FB Medizin der Johann-Wolfgang Goethe-Universität
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients (> 18 yrs) with known or who are highly suspicious of having Spondylarthritides (SpA) with axial involvement and inflammatory back pain and are indicated for contrast-enhanced MRI of the pelvis • Patients who are willing to undergo study procedures • Patients who are willing and able to sign informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • • Patients who have previously entered this study • Patients who are in pregnancy or nursery. In women with child bearing potential a pregnancy test must be performed directly before each MR examination in order to safely exclude pregnancy. • Patients with any physical or mental status that interferes with the signing of informed consent • Patients with a contraindication for MRI • Patients who have received any contrast material within 12 hours prior to injection with study, comparator or similar drug in combination with moderate or severe renal impairment. • Patients who require emergency treatment • Patients with severely impaired hepatic function (e.g. SGPT equal or more than 2 times the upper limit of reference range) • Patients with impaired renal function of CKD stadium 3 and higher (e.g. creatinine clearance < 60ml/ min). In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. • Patients with underlying disease or concomitant medication which may interfere with efficacy evaluation • Patients with known anaphylactoid or anaphylactic reaction to any contrast media.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to prove, that Gadovist® 1.0 provides superior contrast enhancement characteristics of inflammatory tissue in the pelvis as compared to Dotarem®, thereby providing superior information for further diagnostic and/ or therapeutic decisions.;Secondary Objective: ;Primary end point(s): Technical (quantitative) assessment of the change of… • Signal intensity of the bone in post-contrast T1-weighted images measured in the second T1 VIBE sequence after contrast administration | — |
Countries
Germany
Outcome results
None listed