Idiopathic Pulmonary Fibrosis MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intr
Sponsors
Academic Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients to be included must meet the following criteria: 1. Diagnosis of IPF(2): a) If possible a thoracoscopic or open lung biopsy showing UIP. A thoracoscopic or open lung biopsy must be performed in patients 50 years fulfilling all above mentioned criteria a BAL to exclude other causes of interstitial lung disease is sufficient and a lung biopsy is not necessary. 2. Show stable disease or failure to respond to standard medication (i.e. azathioprine and prednisolone) (as defined by the ATS/ERS criteria(2)) during a minimum of 3 months prior to the study, with a minimum dose of prednisolone (or equivalent) of 20 mg daily, and azathioprine 2 mg per kg with a maximum of 200 mg daily during 3 months. 3. Men and women between 40 and up until 79 years. 4. Disease duration between 3 months and 2 years. 5. Men and women must use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion. 6. The screening laboratory test results must meet the following criteria: a. Haemoglobin ³ 8.5 g/dL (5.3 mmol/L) b. WBC ³ 3.5 x 109/L c. Neutrophils ³ 1.5 x 109/L d. Platelets ³ 100 x 1012/L e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test. 7. Patient must be able to adhere to the study visit schedule and other protocol requirements. 8. Patient must be able to communicate meaningfully with the study personnel. 9. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures. 10. Must have a chest radiograph within 3 months prior to first infusion with no evidence of malignancy or infection. 11. Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules as decribed in section 4.3. 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 will be excluded from this study for any of the following reasons: 1. Critical low lung function: FVC 3 months prior to screening). 18. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 19. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly. 20. Known recent substance abuse (drug or alcohol). 21. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period. 22. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Section 4.3.2.1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of the study are to establish that the administration of monoclonal antibody anti-TNF-alpha in patients with IPF: * Affects inflammatory and pro-fibrotic cytokine expression in broncho-alveolar lavage and blood. ;Secondary Objective: * Has a potential beneficial effect on disease progression. * Is tolerable and safe.;Primary end point(s): -Change in FVC from baseline. -Time to disease progression (ATS criteria)(2). | — |
Countries
Germany
Outcome results
None listed