Arthritis, RheumatoidPhase 1NCT02247375
Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)
A Phase 1 study testing Low dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim.
Trial summary
Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Low dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to May 2000
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Low dose of BIIL 284 BS tablets, High dose of BIIL 284 BS tablets, 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.
Low dose of BIIL 284 BS tabletsDrug
High dose of BIIL 284 BS tabletsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BIIL 284 BS | Experimental | Not described Receives: Drug: Low dose of BIIL 284 BS tablets |
| High dose of BIIL 284 BS | Experimental | Not described Receives: Drug: High dose of BIIL 284 BS tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Mac-1 expression
Measured: 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
Measured: Pre-dose, up to day 14 after start of treatment
Maximum concentration of the analyte in plasma (Cmax)
Measured: 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)
Measured: Pre-dose, up to day 14 after start of treatment
Time to reach the maximum concentration of the analyte in plasma (tmax)
Measured: Pre-dose, up to day 14 after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: Pre-dose, up to day 14 after start of treatment
Number of patients with adverse events
Measured: Up to 4 weeks
Global assessment of tolerability by the patient on a 4-point scale
Measured: Up to 14 days after start of treatment
Global assessment of tolerability by investigator on a 4-point scale
Measured: Up to 14 days after start of treatment
Secondary outcomes (14)
Changes from baseline in tender joint count (TJC)
Bilateral assessment of twenty-eight joints by e.g., pressure, joint manipulation etc.
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in swollen joint count (SJC)
Twenty-eight joints were bilaterally assessed whether they are swollen or not
Measured: 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)
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in patient's global assessment of disease activity by VAS
Measured: Pre-dose, up to day 14 after start of treatment
Global assessment of disease activity by investigator on a 5-point scale
Measured: Up to 14 days after start of treatment
Changes from baseline for patient's assessment of physical function
Functional disability was measured using the disability section of the Health Assessment Questionnaire (HAQ)
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in erythrocyte sedimentation rate (ESR)
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in C-reactive protein (CRP)
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in american college of rheumatology (ACR) 20 score
Measured: Pre-dose, up to day 14 after start of treatment
Changes from baseline in disease activity score (DAS)
Measured: Pre-dose, up to day 14 after start of treatment
Global efficacy assessment by the patient on a 4-point scale
Measured: Up to 14 days after start of treatment
Number of withdrawals due to adverse events
Measured: Up to 4 weeks
Number of patients with clinically significant findings in laboratory adverse events
Measured: Up to 4 weeks
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 2000
- Primary completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247375
- Sponsor's protocol ID
- 543.14
- Status last verified
- Sep 2014
- First submitted
- 19 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02247375
- Acronym / sponsor ID
- 543.14
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- May 2000 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female from 18 to 65 years of age
- Patients suffering from active rheumatoid arthritis as defined by the ARA criteria revised 1987
- Patient belonging to the RA functional class I, II or III
- Patient's written informed consent
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Changes from baseline in Mac-1 expression
Time frame: 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
Time frame: Pre-dose, up to day 14 after start of treatment
Maximum concentration of the analyte in plasma (Cmax)
Time frame: 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)
Time frame: Pre-dose, up to day 14 after start of treatment
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time frame: Pre-dose, up to day 14 after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: Pre-dose, up to day 14 after start of treatment
Number of patients with adverse events
Time frame: Up to 4 weeks
Global assessment of tolerability by the patient on a 4-point scale
Time frame: Up to 14 days after start of treatment
Global assessment of tolerability by investigator on a 4-point scale
Time frame: Up to 14 days after start of treatment
14 secondary outcomes
Changes from baseline in tender joint count (TJC)
Time frame: Pre-dose, up to day 14 after start of treatment
Changes from baseline in swollen joint count (SJC)
Time frame: 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)
Time frame: Pre-dose, up to day 14 after start of treatment
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
Global assessment of disease activity by investigator on a 5-point scale
Time frame: Up to 14 days after start of treatment
Changes from baseline for patient's assessment of physical function
Time frame: Pre-dose, up to day 14 after start of treatment
Changes from baseline in erythrocyte sedimentation rate (ESR)
Time frame: Pre-dose, up to day 14 after start of treatment
Changes from baseline in C-reactive protein (CRP)
Time frame: Pre-dose, up to day 14 after start of treatment
Changes from baseline in american college of rheumatology (ACR) 20 score
Time frame: Pre-dose, up to day 14 after start of treatment
Changes from baseline in disease activity score (DAS)
Time frame: Pre-dose, up to day 14 after start of treatment
Global efficacy assessment by the patient on a 4-point scale
Time frame: Up to 14 days after start of treatment
Number of withdrawals due to adverse events
Time frame: Up to 4 weeks
Number of patients with clinically significant findings in laboratory adverse events
Time frame: Up to 4 weeks
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose of BIIL 284 BS tablets and High dose of BIIL 284 BS tablets 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 12 inclusion and 21 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 25 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes from baseline in Mac-1 expression (time frame: Pre-dose, up to day 14 after start of treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2014.