Beryllium Infliximab Study: Clinical Interventional Trial

You may not qualify if:

• Positive tuberculosis (TB) skin test upon screening: An intradermal tuberculin skin test must be performed within 1 month prior to the first administration of study agent.
• Any evidence of TB.
• Considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules.
• Positive pregnancy test.
• Women who are pregnant, nursing, or planning pregnancy within one year after screening
• Contraindications to bronchoscopy and BAL such as bleeding diathesis, PaO2 \<50 mmHg on room air, evidence of acute infection, hemodynamic instability with labile blood pressure, either \<90/60 or \>160/110, untreated coronary artery disease, or other medical reason for which a subject will not be able to safely undergo bronchoscopy.
• Positive cultures from prior BAL indicating mycobacterial or fungal infection.
• Positive special stains for acid fast bacilli (AFB) or fungi on prior lung biopsies.
• Known atypical mycobacterium infection.
• Clinical evidence of active infection at time of enrollment.
• Serious acute infections (e.g., viral hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
• Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
• Documented HIV infection.
• Positive serology for active hepatitis B or C. A positive result will indicate the need for referral to a consultant Hepatologist for further investigation and support.
• Use of any investigational drug within 1 month prior to screening or within 5 half lives of the investigational agent, whichever is longer.
• +12 more criteria