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

NCT02247375 | Completed Phase 1

• 1 other identifier: 543.14
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (9)

• Changes from baseline in Mac-1 expression

  Pre-dose, up to day 14 after start of treatment

• Plasma concentrations of BIIL 284 BS, BIIL 260 BS, BIIL 315 ZW and BIIL 304 ZW

  Pre-dose, up to day 14 after start of treatment

• Maximum concentration of the analyte in plasma (Cmax)

  Pre-dose, up to day 14 after start of treatment

• Trough concentration of the analyte in plasma shortly before drug administration in a steady state dosing interval (Cpre,ss)

  Pre-dose, up to day 14 after start of treatment

• Time to reach the maximum concentration of the analyte in plasma (tmax)

  Pre-dose, up to day 14 after start of treatment

• Area under the concentration-time curve of the analyte in plasma (AUC)

  Pre-dose, up to day 14 after start of treatment

• Number of patients with adverse events

  Up to 4 weeks

• Global assessment of tolerability by the patient on a 4-point scale

  Up to 14 days after start of treatment

• Global assessment of tolerability by investigator on a 4-point scale

  Up to 14 days after start of treatment

Secondary Outcomes (14)

• Changes from baseline in tender joint count (TJC)

  Pre-dose, up to day 14 after start of treatment

• Changes from baseline in swollen joint count (SJC)

  Pre-dose, up to day 14 after start of treatment

• Changes from baseline in patient's current pain level assessment by visual analogue scale (VAS)

  Pre-dose, up to day 14 after start of treatment

• Changes from baseline in patient's global assessment of disease activity by VAS

  Pre-dose, up to day 14 after start of treatment

• Global assessment of disease activity by investigator on a 5-point scale

  Up to 14 days after start of treatment

Study Arms (3)

Low dose of BIIL 284 BS

EXPERIMENTAL

Drug: Low dose of BIIL 284 BS tablets

High dose of BIIL 284 BS

EXPERIMENTAL

Drug: High dose of BIIL 284 BS tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of BIIL 284 BS tablets DRUG

Low dose of BIIL 284 BS

High dose of BIIL 284 BS tablets DRUG

High dose of BIIL 284 BS

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

amelubant

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: January 1, 2000
• Primary Completion: May 1, 2000
• Last Updated: September 25, 2014

Record last verified: 2014-09