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

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ClinicalTrials.gov Identifier: NCT02247375
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Low dose of BIIL 284 BS tablets Drug: High dose of BIIL 284 BS tablets Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks
Study Start Date : January 2000
Actual Primary Completion Date : May 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose of BIIL 284 BS Drug: Low dose of BIIL 284 BS tablets
Experimental: High dose of BIIL 284 BS Drug: High dose of BIIL 284 BS tablets
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Changes from baseline in Mac-1 expression [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  2. Plasma concentrations of BIIL 284 BS, BIIL 260 BS, BIIL 315 ZW and BIIL 304 ZW [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  3. Maximum concentration of the analyte in plasma (Cmax) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  4. Trough concentration of the analyte in plasma shortly before drug administration in a steady state dosing interval (Cpre,ss) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  5. Time to reach the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  6. Area under the concentration-time curve of the analyte in plasma (AUC) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  7. Number of patients with adverse events [ Time Frame: Up to 4 weeks ]
  8. Global assessment of tolerability by the patient on a 4-point scale [ Time Frame: Up to 14 days after start of treatment ]
  9. Global assessment of tolerability by investigator on a 4-point scale [ Time Frame: Up to 14 days after start of treatment ]

Secondary Outcome Measures :
  1. Changes from baseline in tender joint count (TJC) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
    Bilateral assessment of twenty-eight joints by e.g., pressure, joint manipulation etc.

  2. Changes from baseline in swollen joint count (SJC) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
    Twenty-eight joints were bilaterally assessed whether they are swollen or not

  3. Changes from baseline in patient's current pain level assessment by visual analogue scale (VAS) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  4. Changes from baseline in patient's global assessment of disease activity by VAS [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  5. Global assessment of disease activity by investigator on a 5-point scale [ Time Frame: Up to 14 days after start of treatment ]
  6. Changes from baseline for patient's assessment of physical function [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
    Functional disability was measured using the disability section of the Health Assessment Questionnaire (HAQ)

  7. Changes from baseline in erythrocyte sedimentation rate (ESR) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  8. Changes from baseline in C-reactive protein (CRP) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  9. Changes from baseline in american college of rheumatology (ACR) 20 score [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  10. Changes from baseline in disease activity score (DAS) [ Time Frame: Pre-dose, up to day 14 after start of treatment ]
  11. Global efficacy assessment by the patient on a 4-point scale [ Time Frame: Up to 14 days after start of treatment ]
  12. Number of withdrawals due to adverse events [ Time Frame: Up to 4 weeks ]
  13. Number of patients with clinically significant findings in laboratory adverse events [ Time Frame: Up to 4 weeks ]
  14. Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: Up to 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02247375     History of Changes
Other Study ID Numbers: 543.14
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases