Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000205538
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infliximab in the treatment of Polymyalgia Rheumatica
Scientific title
Prednisolone and Infliximab for Polymyalgia Rheumatica: Evaluation of the safety and efficiacy of Infliximab in maintaining Corticosteroid-induced remission and in sparing Corticosteroids
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyalgia rheumatica 1183 0
Condition category
Condition code
Musculoskeletal 1266 1266 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to receive infusions of infliximab 3 mg/Kg, respectively, at weeks 0, 2, 6, 14, 22. All patients will be treated with oral prednisone according to a fixed tapering protocol with a starting daily dosage of 15 mg tapered to 0 in 16 weeks. Prednisone dosage will be increased/restarted if flare-ups occurred. Patients will be evaluated every 4 weeks during the 52 week follow-up period.
Intervention code [1] 1042 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1707 0
The predefined primary efficacy end point is the proportion of relapse/recurrence free patients
Timepoint [1] 1707 0
Measured at week 52
Secondary outcome [1] 3056 0
The proportion of relapse/recurrence free patients
Timepoint [1] 3056 0
Measured at week 22
Secondary outcome [2] 3057 0
The proportion of patients no longer taking steroids
Timepoint [2] 3057 0
At week 22 and at week 52
Secondary outcome [3] 3058 0
The total number of relapses or recurrences
Timepoint [3] 3058 0
During the 52-week study period
Secondary outcome [4] 3059 0
The duration of prednisone therapy
Timepoint [4] 3059 0
During the 52-week study period
Secondary outcome [5] 3060 0
The cumulative dose of prednisone
Timepoint [5] 3060 0
During the 52-week study period
Secondary outcome [6] 3061 0
The number of patients with adverse events
Timepoint [6] 3061 0
During the 52-week study period.

Eligibility
Key inclusion criteria
Consecutive adult patients who satisfy Healey’s criteria for the diagnosis of PMR will be included in the study.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients previously treated with corticosteroids; 2) Patients with clinical and/or histological evidence of giant cell arteritis; 3) Uncontrolled diabetes and hypertension, infection and neoplasm;4) Active or inactive (latent) Tuberculosis (TB), evaluated by detailed medical history (including personal history of TB, possible previous contacts with TB, and family history of TB), chest X-rays (performed in the 2 months prior entering the study), and PPD test. If any of those are positive or suggestive of TB the patient can not be enrolled.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment outside Australia
Country [1] 317 0
Italy
State/province [1] 317 0

Funding & Sponsors
Funding source category [1] 1386 0
Hospital
Name [1] 1386 0
Reggio Emilia Hospital
Country [1] 1386 0
Funding source category [2] 1387 0
Commercial sector/Industry
Name [2] 1387 0
Centocor
Country [2] 1387 0
United States of America
Primary sponsor type
Hospital
Name
Hospital S. Maria Nuova, Reggio Emilia Italy
Address
Country
Italy
Secondary sponsor category [1] 1220 0
Charities/Societies/Foundations
Name [1] 1220 0
Italian Society of Rheumatology
Address [1] 1220 0
Country [1] 1220 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2736 0
Ethic Committee of Reggio Emilia Hospital
Ethics committee address [1] 2736 0
Reggio Emilia
Ethics committee country [1] 2736 0
Italy
Date submitted for ethics approval [1] 2736 0
Approval date [1] 2736 0
Ethics approval number [1] 2736 0
41
Ethics committee name [2] 2737 0
Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali del Ministero della Salute Italiana
Ethics committee address [2] 2737 0
Ethics committee country [2] 2737 0
Italy
Date submitted for ethics approval [2] 2737 0
Approval date [2] 2737 0
24/09/2001
Ethics approval number [2] 2737 0
R02

Summary
Brief summary
Glucocorticoids have been the treatment of choice for polymyalgia rheumatica but are commonly associated with serious adverse events even when given in lower doses. A reliable alternative to glucocorticoids or an acceptable steroid-sparing drug has not been identified. A recent pilot study suggested that infliximab may have a steroid-sparing effect in the treatment of polymyalgia rheumatica.
The primary purpose of this double blind,randomized, placebo controlled study is to evaluate the efficacy and safety of infliximab in maintaining glucocorticosteroid-induced remission and in sparing corticosteroids in newly diagnosed polymyalgia rheumatica patients.
Patients, investigators, and study personnel will be blinded to treatment assignments during the study, with the exception of the site pharmacists who prepare study medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35294 0
Address 35294 0
Country 35294 0
Phone 35294 0
Fax 35294 0
Email 35294 0
Contact person for public queries
Name 10231 0
Carlo Salvarani
Address 10231 0
Rheumatology Unit
Hospital of Reggio Emilia
V.le Risorgimento N 80
42100 Reggio Emilia
Country 10231 0
Italy
Phone 10231 0
+39 0522296616
Fax 10231 0
+39 0522295836
Email 10231 0
salvarani.carlo@asmn.re.it
Contact person for scientific queries
Name 1159 0
PierLuigi Macchioni
Address 1159 0
Rheumatology Unit
Hospital of Reggio Emilia
V.le Risorgimento N 80
42100 Reggio Emilia
Country 1159 0
Italy
Phone 1159 0
+39 0522296883
Fax 1159 0
+39 0522295836
Email 1159 0
macchioni.pierluigi@asmn.re.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.