Status:
COMPLETED
Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Safety, pharmacokinetics, pharmacodynamics \[CD11b/CD18 (Mac-1) expression\] and efficacy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02247375
Start Date
January 1 2000
Last Update
September 25 2014
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