pharmacokinetics, safety and efficacy of biil 284 bs in patients with rheumatoid arthritis (ra)

Conditions: Arthritis, Rheumatoid

Summary: safety, pharmacokinetics, pharmacodynamics \[cd11b/cd18 (mac-1) expression\] and efficacy.


Eligibility criteria:
inclusion criteria: * male and female from 18 to 65 years of age * patients suffering from active rheumatoid arthritis as defined by the ara criteria revised 1987 --- at least 4 of the following 7 criteria must have been present: * morning stiffness in and around the joints lasting at least 1 hour before maximal improvement for at least 6 weeks * arthritis (soft tissue thickening or fluid - not bony overgrowth alone) of at least 3 joint areas for at least 6 weeks * arthritis of hand joints (at least one area swollen in a wrist, metacarpophalangeal (mcp) or proximal interphalangeal (pip) joint) for at least 6 weeks * symmetric arthritis (observed by a physician) with simultaneous involvement of the joints on both sides of the body for at least 6 weeks * rheumatoid nodules (observed by a physician) over bony prominences or extensor surfaces or in juxta-articular regions * serum rheumatoid factor positive * x-ray changes typical of rheumatoid arthritis (erosions or unequivocal bony decalcification localised in or most marked adjacent to the involved joints) * patient belonging to the ra functional class i, ii or iii * patient's written informed consent exclusion criteria: * pregnancy (to be excluded by pregnancy test) or breast feeding * women of childbearing potential not using adequate contraception * treatment with methotrexate in the previous month or intended use during the trial period * treatment with slow acting antirheumatic drugs (saards)/disease-modifying antirheumatic drugs (dmards) other than parenteral gold, d-penicillamine, sulfasalazine, chloroquine / hydroxychloroquine corticosteroid during the last 2 months prior to study entry * treatment with more than one saard/dmard and/or corticosteroid during the last 2 months prior to study entry * change in treatment with saards/dmards during the last 2 months prior to study entry or intended change during the trial duration * change in treatment with corticosteroids during the last month prior to study entry or intended change during the trial duration * systemic treatment with corticosteroids at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent), respectively (whichever is lower) during the last month prior to study entry or their intended use during the trial treatment period * change in treatment with non-steroidal anti-inflammatory drugs (nsaids) during the last month prior to study entry or intended change during the trial duration * treatment with enbreltm (etanercept) or experimental therapies during the last 3 months prior to study entry * synovectomy and/or surgical treatment for ra in the previous month or during the trial * clinical evidence of known severe cardiovascular, hepatic, renal, respiratory, metabolic, haematological, immunological, gastro-intestinal, hormonal or mental disorders * any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety * patients with active malignant disease * patients with chronic or acute infections during the previous month * patients with abnormal, clinically relevant laboratory values not related to ra * participation in another clinical trial during this study or during the previous month * previous participation in this trial (i.e. having been allocated a randomized treatment number) * patient unable to comply with the protocol * patient with known drug abuse * patient with known alcohol abuse