Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

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