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Arthritis, RheumatoidPhase 2NCT02209779

Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid Arthritis

A Phase 2 study testing BIBR 796 BS 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

The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety parameters Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
BIBR 796 BS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
No sites listed yet
Study dates
May 2001to Jun 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female from 18 to 75 years of age
  • Diagnosis of Rheumatoid Arthritis (RA) established according to ACR criteria and date of diagnosis >1 year to ≤ 15 years. The exclusion of patients with a disease duration > 15 years was deleted in Amendment 2, effective January 22, 2002
  • Patient belonging to functional class I, II, or III
  • Failure of at least one Disease Modifying Antirheumatic Drug (DMARD) due to inefficacy
  • Active disease, documented at visit 3, defined by ≥10 swollen joints in a 66 joint count and ≥ 12 tender joints in a 68 joint count
  • CRP ≥ 2.0 mg/dl at visit 1 or visit 2
  • Written informed consent in accordance with Good Clinical Practice and local legislation given prior to any study procedures, including washout of prohibited medications

Who cannot join

  • Pregnancy (to be excluded by serum and urine β Human Chorion-Gonadotropin-test in women of childbearing potential) or breast feeding
  • Female of childbearing potential (not 6 months post-menopausal or surgically sterilized) not using an approved form of birth control (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (IUD))
  • Inflammatory rheumatic disease other than RA
  • Active vasculitis or any history of vasculitis (characterised by e.g. nail bed hemorrhages or infarcts, vasculitic purpura, ulcers or gangrenes, multisensory neuropathy, vasculitic retinopathy or scleritis of eyes). Isolated rheumatoid nodules of the skin are not a criterion for exclusion
  • Treatment failure to a TNF-blocking agent. Treatment failure is defined as not achieving at least an ACR 20 response (e.g. in a clinical trial) or - in clinical practice - having the TNF-blocking agent discontinued due to ineffectiveness
  • DMARD treatment within 4 weeks before visit 3
Show all 34Show fewer
  • Last dose given within the specified time period before visit 3 for one of the following compounds or drugs:
  • Infliximab (Remicade®): 3 months
  • D2E7 (a human TNF-α antibody): 3 months
  • Leflunomide (Arava®): 1 year, with exception of patients having undergone elimination therapy (colestyramin 8 grams t.i.d. po for eleven consecutive days), this exclusion criterion was deleted in Amendment 1, effective September 3, 2001
  • Drug classified as proton pump inhibitor: 7 days
  • Drug classified as H2-receptor-blocker or antacid: 2 days
  • Investigational agent: 5-fold of the respective plasma half life or 4 weeks, whichever is longer
  • Treatment with systemic corticosteroids in a dose higher than 10 mg/day prednisone equivalent within 4 weeks prior to visit 3
  • Change in treatment with nonsteroidal antiinflammatory drugs (NSAIDs) or systemic corticosteroids within 4 weeks prior to visit 3
  • Synovectomy, joint surgery, radio-/chemo synoviorthesis or steroid injections (intraarticular, intravenous or intramuscular) within 4 weeks before visit 3
  • Active infection or serious infectious diseases resulting in hospitalisation or requiring systemic anti-infective therapy within 4 weeks before visit 3
  • Serologic evidence of active hepatitis B and/or C
  • Known HIV-infection
  • History of prior tuberculosis infection or suspicion of active infection at screening based on chest x-ray done within 6 month before visit 1
  • History of cardiovascular, renal, neurologic, psychiatric, liver, gastrointestinal, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
  • Recent history of heart failure, defined according to New York Heart Association criteria as being stage III or IV (i.e. three years or less) or myocardial infarction (i.e. one year or less) or patients with any cardiac arrhythmia requiring drug therapy. This exclusion criterion was slightly modified in Amendment 2, effective January 22, 2002.
  • ECG results outside of the reference range of clinical relevance including, but not limited to QTcB > 480 msec, PR interval > 240 msec, QRS interval > 110 msec
  • History of malignant disease in the last 5 years or suspicion of active malignant disease except successfully treated squamous or basal cell carcinoma of the skin
  • Clinically significant abnormal baseline hematology, blood chemistry or urinalysis if the abnormality defines a disease listed as an exclusion criterion
  • Any of the following specific laboratory abnormalities:
  • Alanine aminotransferase, aspartate aminotransferase, or total bilirubin greater than upper limit of normal (ULN) at visit 1 or measured within the last six months before visit 3. This exclusion criterion was modified in Amendment 1, effective September 3, 2001, allowing for a retest at Visit 2.
  • Gamma-Glutamyltransferase, alkaline phosphatase or Lactate Dehydrogenase greater than 1.5 x ULN at visit 1
  • creatinine or white blood cell count greater than 1.5 x ULN at visit 1
  • History of drug or alcohol abuse within the past two years or active drug or alcohol abuse, present alcohol intake more than three drinks per day
  • Inability to comply with the protocol
  • Participation in another clinical trial within 30 days before visit 3
  • Previous enrolment in this trial
  • Hypersensitivity to trial drug

About this study

Official title: A Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety parameters

Being tested
BIBR 796 BS, 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.

  • BIBR 796 BSDrug

  • PlaceboDrug

Study groups in NCT02209779
Study groupRoleWhat they receive
BIBR 796 BS, low doseExperimentaltwice daily doses of 5 mg for 4 weeks
Receives: Drug: BIBR 796 BS; Drug: Placebo
BIBR 796 BS, medium dose 1Experimentaltwice daily doses of 10 mg for 4 weeks
Receives: Drug: BIBR 796 BS; Drug: Placebo
BIBR 796 BS, medium dose 2Experimentaltwice daily doses of 20 mg for 4 weeks
Receives: Drug: BIBR 796 BS; Drug: Placebo
BIBR 796 BS, high doseExperimentaltwice daily doses of 30 mg for 4 weeks
Receives: Drug: BIBR 796 BS
PlaceboActive comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Absolute difference to baseline in concentrations of C-reactive Protein (CRP)

    Measured: before and after 4 weeks of treatment

Secondary outcomes (16)

  1. Absolute difference to baseline in tender joint count (TJC, 68 joint count)

    Measured: before and after 4 weeks of treatment

  2. Absolute difference to baseline in swollen joint count (SJC, 66 joint count)

    Measured: before and after 4 weeks of treatment

  3. Patients assessment of pain on a visual analogue scale (VAS)

    Measured: up to 57 days

  4. Patients global assessment of disease activity (PADA) on a VAS

    Measured: up to 57 days

  5. Physicians global assessment of disease activity on a VAS

    Measured: up to 57 days

  6. Assessment of physical function by a standardised health assessment questionnaire (HAQ)

    Measured: up to 57 days

  7. Absolute difference to baseline in Erythrocyte sedimentation rate (ESR)

    Measured: up to 57 days

  8. Absolute difference to baseline in Cytokines Tumor Necrosis Factor (TNF)-α, soluble TNF-Receptor (sTNF-R), Interleukin (IL)-1ra, IL-6

    Measured: Day 1, 8 and 29

  9. Absolute difference to baseline in Matrix metalloprotease-3 (MMP-3)

    Measured: Day 1, 8 and 29

  10. Absolute difference to baseline in Vascular endothelial growth factor (VEGF)

    Measured: Day 1, 8 and 29

  11. Number of responders to American College of Rheumatology (ACR) preliminary response criteria for 20% improvement (ACR 20), ACR 50, ACR 70

    Measured: after 4 weeks of treatment

  12. Number of responders to European League against Rheumatism (EULAR) response criteria

    Measured: after 4 weeks of treatment

  13. Number of drop-outs due to lack of efficacy, according to final assessment of investigator

    Measured: after 4 weeks of treatment

  14. Assessment of maximum concentration (Cmax)

    Measured: Day 15, 22, 29

  15. Assessment of area under the curve (AUC) at steady state

    Measured: Day 15, 22, 29

  16. Number of patients with Adverse events

    Measured: up to day 73

Timeline

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

  1. First posted6 Aug 2014 (estimated)
  2. Study startMay 2001
  3. Primary completionJun 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
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209779
Sponsor's protocol ID
1175.11
Status last verified
Aug 2014
First submitted
5 Aug 2014
Last updated
6 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBR 796 BS 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 7 inclusion and 34 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 6 Aug 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. 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?

Absolute difference to baseline in concentrations of C-reactive Protein (CRP) (time frame: before and after 4 weeks of treatment). 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 NCT02209779.

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 6 Aug 2014.

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