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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001285
ACTR Number: ACTRN12606000205538
Trial Status: Registered
Date Submitted: 16/05/2006
Date Registered: 29/05/2006

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Public title: Infliximab in the treatment of Polymyalgia Rheumatica
ANZCTR registration title: Prednisolone and Infliximab for Polymyalgia Rheumatica: Evaluation of the safety and efficiacy of Infliximab in maintaining Corticosteroid-induced remission and in sparing Corticosteroids
Secondary ID: 
UTN:
Trial acronym:

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

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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:None 
Comparator / control treatment: Placebo
Control group: Placebo

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

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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
Gender: Both males and females
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Central randomisation by phone
Describe the 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: The people receiving the treatment/s
 The people administering the treatment/s
 The people assessing the outcomes
 The people analysing the results/data
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase
Anticipated or actual date of first participant enrolement: 7/02/2002
Target sample size: 51
Recruitment status: Completed

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Funding source 1:Hospital 
Name:Reggio Emilia Hospital 
Address: 
Country: 
Funding source 2:Commercial sector/Industry 
Name:Centocor 
Address: 
Country:United States of America 
Primary sponsor: Hospital
Name: Hospital S. Maria Nuova, Reggio Emilia Italy
Address:
Country: Italy
Secondary sponsor:Charities/Societies/Foundations 
Name:Italian Society of Rheumatology 
Address: 
Country:Italy 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Ethic Committee of Reggio Emilia Hospital 
Address:Reggio Emilia 
Country:Italy 
Date of approval: 
HREC Number:41 
Ethics Committee name 2:Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali del Ministero della Salute Italiana 
Address: 
Country:Italy 
Date of approval:24/09/2001 
HREC Number:R02 
Countries of recruitment:Outside Australia 
Italy 
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:
Presentations / publication list:

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Contact person for public queries
Name: Carlo Salvarani
Address: Rheumatology Unit Hospital of Reggio Emilia V.le Risorgimento N 80 42100 Reggio Emilia
Country: Italy
Tel: +39 0522296616
Fax: +39 0522295836
Email: salvarani.carlo@asmn.re.it

Contact person for scientific queries
Name: PierLuigi Macchioni
Address: Rheumatology Unit Hospital of Reggio Emilia V.le Risorgimento N 80 42100 Reggio Emilia
Country: Italy
Tel: +39 0522296883
Fax: +39 0522295836
Email: macchioni.pierluigi@asmn.re.it

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