Efficacy and Safety of BIIL 284 BS in Adult Patients With Active Rheumatoid Arthritis

NCT02251210 | Completed Phase 2

• 1 other identifier: 543.27
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate efficacy and safety of 3 doses of BIIL 284 BS in active rheumatoid arthritis (RA) and determine the dose with most positive efficacy / safety ratio. Pharmacokinetic profile will be also obtained.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving 20% improvement assessed by the American College of Rheumatology (ACR) criteria (ACR20)

  3 months

Secondary Outcomes (21)

• Percentage of patients achieving 50% improvement (ACR50)

  3 months

• Number of withdrawals due to lack of efficacy

  up to 3 months

• Number of swollen joints

  up to 3 months

• Number of tender joints

  up to 3 months

• Patient's assessment of pain on a visual analog scale (VAS)

  up to 3 months

Study Arms (4)

BIIL 284 BS low dose

EXPERIMENTAL

Drug: BIIL 284 BS low dose

BIIL 284 BS medium dose

EXPERIMENTAL

Drug: BIIL 284 BS medium dose

BIIL 284 BS high dose

EXPERIMENTAL

Drug: BIIL 284 BS high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIL 284 BS low dose DRUG

BIIL 284 BS low dose

BIIL 284 BS medium dose DRUG

BIIL 284 BS medium dose

BIIL 284 BS high dose DRUG

BIIL 284 BS high dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of \>=18 and \<= 70 years of age
• Patients suffering from rheumatoid arthritis as defined by the American Rheumatism Association (ARA) criteria revised 1987 and date of diagnosis \>= 6 months. At least 4 of the following 7 criteria must be 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
• Symmetrical 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 prominence or extensor surfaces or in juxta-articular regions
• Serum rheumatoid factor positive
• X-ray changes typical of rheumatoid arthritis (erosions or unequivocal bony decalcification localized in or most marked adjacent to the involved joints)
• Patients belonging to the RA functional class I, II or III
• Active RA as defined at visit 2 by:
• Swollen joint count at least of 6 (of 28 joints examined) and
• Tender joint count at least of 8 (of 28 joints examined) and
• Patients must fulfil 2 out of the 3 following criteria:
• Patient's assessment of pain (VAS) \>= 40 mm

You may not qualify if:

• Patient presenting or having a history of inflammatory rheumatic disease other than RA (e.g.: mixed connective tissue disease, systemic lupus erythematosus, seronegative spondyloarthropathy)
• Patients who have failed to more than 3 different disease-modifying antirheumatic drug (DMARDs) therapies previously due to lack of efficacy (in case of combined therapy each DMARDs used is counted as one)
• Patients with any other disease that could interfere with the evaluation of efficacy and safety
• Patients in treatment with any DMARDs / slow-acting anti-rheumatic drug (SAARDs) during the periods specified:
• weeks before V2: Methotrexate, parenteral/oral gold, D-penicillamine, Sulphasalazine, antimalarials (e.g.:Chloroquine/Hydroxychloroquine), Azathioprine, Cyclosporine A, Alkylating agents (e.g.: Cyclophosphamide / Chlorambucil), Minocycline, Etanercept (Enbrel®), and Leflunomide (only if wash-out with Colestyramine has been done after leflunomide discontinuation)
• months before Visit 2: Leflunomide if no wash- out with colestyramine has been done after leflunomide discontinuation, Infliximab (Remicade®), any other biological compound.
• Patient in treatment with oral corticosteroids at a dose higher than 10 mg/day or 0.2 mg/Kg/day (prednisone equivalent) whichever is lower, during the 4 weeks prior to Visit 2, change in the treatment with oral corticosteroids during the 4 weeks prior to Visit 2 or intended change during the trial
• Patients in treatment with any parenteral (intravenous, intramuscular or intraarticular) treatment with corticosteroids during the 4 weeks prior to Visit 2 or their intended use during the trial.
• Change in treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during the 2 weeks prior to Visit 2 or any intended change during the trial.
• Synovectomy, and/or surgical treatment for RA in the previous 3 months prior to visit 2 or intended indication during the trial.
• Synoviorthesis in the previous 4 weeks prior to Visit 2 or intended indication during the trial.
• Patients in treatment with any other leukotriene inhibitors such as montelukast or zafirlukast 4 weeks prior to Visit 2 or intended use during the trial.
• Initiation of physiotherapy during the 2 weeks before V2, or intended change during the trial
• Patients with history of cardiovascular, renal, neurologic, psychiatric, liver, gastrointestinal (including lactose intolerance ), immunologic or endocrine dysfunction if they are clinically significant.
• Patients with any other known condition or circumstance, which would in the investigator's opinion, prevents compliance or completion of the study

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: May 1, 2001
• Primary Completion: November 1, 2002
• Last Updated: September 29, 2014

Record last verified: 2014-09