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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Low dose of BIIL 284 BS tablets

Drug: Placebo

Drug: High dose of BIIL 284 BS tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02247375

543.14

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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