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Arthritis, RheumatoidPhase 2NCT02251210

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

A Phase 2 study testing BIIL 284 BS low dose, BIIL 284 BS medium dose and BIIL 284 BS high dose in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
BIIL 284 BS low dose, BIIL 284 BS medium dose and BIIL 284 BS high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
No sites listed yet
Study dates
May 2001to Nov 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Investigator's global assessment of disease activity on a VAS >= 40 mm
  • ESR >= 28 mm/h or CRP >= 20 mg/L
  • Patient's written informed consent obtained at Visit 1 (screening) before enrolment in the study

Who cannot join

  • 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:
  • 4 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)
  • 3 months before Visit 2: Leflunomide if no wash- out with colestyramine has been done after leflunomide discontinuation, Infliximab (Remicade®), any other biological compound.
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  • 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
  • Patients with history of cancer within the past 5 years, excluding treated basal cell carcinoma
  • Patients with chronic infection or acute infections during the 4 weeks before visit 1
  • Patients with known positive serology for hepatitis B or C
  • Patients with anticoagulant treatment (i.e. dicumarol or derivatives, warfarin)
  • Any of the following abnormal laboratory parameters at Visit 2:
  • Impaired hepatic function, defined by serum levels of either Aspartate Aminotransferase (AST)(SGOT), Alanine Aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin > 2 x upper limit of normal (ULN)
  • Impaired renal function, defined by serum creatinine > 133 mmol/L (1.5 mg/dl)
  • Hemoglobin values < 10 g/dl
  • White blood cell count <= 3.500 cells/mm3
  • Platelet count of less than 120.000/mm3
  • Severe hypoproteinemia (e.g. in case of severe liver disease or nephrotic syndrome) with albumin < 3.0 g/dl
  • Patients with any other abnormal, clinically relevant laboratory values not related to RA
  • Patients participating in another clinical trial during the 3 months prior to visit 2
  • Previous participation in the randomised period of this study
  • Patients with a significant history and/or active alcohol or drug abuse Significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study
  • Pregnancy (to be excluded by pregnancy test at visit 1) or breast feeding, and sexually active women with childbearing potential not using a medically approved method of contraception (i.e. oral contraceptives, intrauterine devices, or double-barrier) for at least one month before and throughout the study period

About this study

Official title: Three Month, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multiple Dose-range Study of the Efficacy and Safety of BIIL 284 BS (5, 25 and 75 mg p.o. Once Daily) in Adult Patients With Active Rheumatoid Arthritis

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.

Being tested
BIIL 284 BS low dose, BIIL 284 BS medium dose, BIIL 284 BS high dose, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIL 284 BS low doseDrug

  • BIIL 284 BS medium doseDrug

  • BIIL 284 BS high doseDrug

  • PlaceboDrug

Study groups in NCT02251210
Study groupRoleWhat they receive
BIIL 284 BS low doseExperimentalNot described
Receives: Drug: BIIL 284 BS low dose
BIIL 284 BS medium doseExperimentalNot described
Receives: Drug: BIIL 284 BS medium dose
BIIL 284 BS high doseExperimentalNot described
Receives: Drug: BIIL 284 BS high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (21)

  1. Percentage of patients achieving 50% improvement (ACR50)

    Measured: 3 months

  2. Number of withdrawals due to lack of efficacy

    Measured: up to 3 months

  3. Number of swollen joints

    Measured: up to 3 months

  4. Number of tender joints

    Measured: up to 3 months

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

    Measured: up to 3 months

  6. Patient's global assessment of disease activity by VAS

    Measured: up to 3 months

  7. Investigator's global assessment of disease activity by VAS

    Measured: up to 3 months

  8. Patient's assessment of physical function

    via Health Assessment Questionnaire (HAQ)

    Measured: up to 3 months

  9. Change in erythrocyte sedimentation rate (ESR)

    Measured: up to 3 months

  10. Change in C-reactive protein (CRP)

    Measured: up to 3 months

  11. Change in Quality of Life

    assessed by the SF-36 questionnaire

    Measured: baseline, 3 months

  12. Change in Disease Activity Score (DAS 28)

    Disease Activity Score in 28-joint count

    Measured: baseline, up to 3 months

  13. Change in duration of morning stiffness

    Measured: up to 3 months

  14. Consumption of rescue medication

    Measured: up to 3 months

  15. Number of patients with adverse events

    Measured: up to 3 months

  16. Number of withdrawals due to adverse events

    Measured: up to 3 months

  17. Final global assessment of tolerability by investigator on a 4-point scale

    Measured: 3 months

  18. Patient's assessment of fatigue by VAS

    Measured: up to 3 months

  19. Number of patients with clinically significant changes in laboratory findings

    Measured: up to 3 months

  20. Number of patients with clinically significant changes in vital signs

    Measured: up to 3 months

  21. Number of patients with clinically significant changes in 12-lead ECG

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2014 (estimated)
  2. Study startMay 2001
  3. Primary completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02251210
Sponsor's protocol ID
543.27
Status last verified
Sep 2014
First submitted
25 Sep 2014
Last updated
29 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIL 284 BS low dose, BIIL 284 BS medium dose and BIIL 284 BS high dose in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving 20% improvement assessed by the American College of Rheumatology (ACR) criteria (ACR20) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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