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Arthritis, RheumatoidPhase 2NCT02214888

Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid Arthritis

A Phase 2 study testing BIRB 796 BS, low dose and BIRB 796 BS, high dose in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study to determine the efficacy (including American College of Rheumatology (ACR) 20 response rate), safety, and pharmacokinetics of BIRB 796 BS as monotherapy in patients with moderate to severe rheumatoid arthritis who have failed at least one disease modifying antirheumatic drug (DMARD) 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?
BIRB 796 BS, low dose and BIRB 796 BS, high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
No sites listed yet
Study dates
May 2003to Jan 2004
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 > 6 months
  • Patient belonging to functional class I, II, or III
  • Failure of at least one DMARD due to lack of efficacy or tolerability
  • 2 out of the 3 following RA activity criteria: If this criterion is not met at visit 1, the whole set of RA activity criteria can be repeated at visit 2 (Repeated screening)
  • documentation of ≥ 9 swollen joints in a 66 joint count
Show all 10Show fewer
  • documentation of ≥ 9 tender joints in a 68 joint count
  • C-reactive protein (CRP) ≥ 1.5 mg/dl or erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr (or equivalent of ≥ 24mm/hr according to Panchenkov method)
  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation given prior to any study procedures, including washout of prohibited medications
  • Only for centres participating in the pharmacokinetic (PK) substudy: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial

Who cannot join

  • Inflammatory rheumatic disease other than RA
  • Treatment failure to a tumor necrosis factor (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
  • History of vasculitis (characterised by e.g. nail bed hemorrhages or infarcts, vasculitic purpura, ulcers or gangrene, multisensory neuropathy, vasculitic retinopathy or scleritis of eyes). Isolated rheumatoid nodules of the skin are not a criterion for exclusion
  • 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 results of chest x-ray not older than 6 months
Show all 32Show fewer
  • 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 (i.e. three years or less) or myocardial infarction (i.e. one year or less) or patients with any cardiac arrhythmia requiring drug therapy
  • 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
  • Screening 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 according to central ECG evaluation
  • Clinically significant abnormal baseline hematology, blood chemistry or urinalysis if the abnormality defines a disease listed as an exclusion criterion or any of the following specific laboratory abnormalities: If this criterion is not met at visit 1, the laboratory assessments can be selectively repeated at visit 2 (Repeated screening)
  • alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than upper limit of normal (ULN)
  • alkaline phosphatase, creatinine or white blood cell count greater than 1.5 x ULN
  • 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
  • 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))
  • Inability to comply with the protocol
  • Previous enrolment in this trial or previous exposure to BIRB 796 BS in another trial
  • Hypersensitivity to trial drug
  • To be assessed at visit 3 (Baseline):
  • Pregnancy (to be excluded by serum and urine beta human chorion-gonadotropin (βHCG)-test in women of childbearing potential) or breast feeding
  • Active vasculitis
  • Active infection or serious infectious diseases resulting in hospitalisation or requiring systemic anti-infective therapy within the last 4 weeks
  • DMARD treatment within the last 4 weeks
  • Last dose given within the specified time period for one of the following compounds or drugs:
  • Infliximab (Remicade®): 3 months
  • Adalimumab (D2E7): 3 months
  • Leflunomide: 3 months. If cholestyramine has been given for 10 days : 4 weeks
  • 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
  • Change in treatment with nonsteroidal antiinflammatory drugs (NSAIDs) or systemic corticosteroids within the last 4 weeks
  • Synovectomy, joint surgery, radio-/chemo synoviorthesis, adrenocorticotropic hormone (ACTH) or any steroid injections (intraarticular, intravenous or intramuscular) within the last 4 weeks
  • Participation in another clinical trial within the last 4 weeks

About this study

Official title: A 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

Study to determine the efficacy (including American College of Rheumatology (ACR) 20 response rate), safety, and pharmacokinetics of BIRB 796 BS as monotherapy in patients with moderate to severe rheumatoid arthritis who have failed at least one disease modifying antirheumatic drug (DMARD)

Being tested
BIRB 796 BS, low dose, BIRB 796 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.

  • BIRB 796 BS, low doseDrug

  • BIRB 796 BS, high doseDrug

  • PlaceboDrug

Study groups in NCT02214888
Study groupRoleWhat they receive
BIRB 796 BS, low doseExperimentalNot described
Receives: Drug: BIRB 796 BS, low dose; Drug: Placebo
BIRB 796 BS, high doseExperimentalNot described
Receives: Drug: BIRB 796 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. Number of responders according to the American College of Rheumatology (ACR) 20 criteria

    Measured: after 12 weeks of treatment

Secondary outcomes (21)

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

    Measured: up to 12 weeks

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

    Measured: up to 12 weeks

  3. Absolute differences to baseline in patients assessment of pain on a visual analogue scale (VAS)

    Measured: up to 12 weeks

  4. Absolute differences to baseline in patients global assessment of disease activity (PADA) on a VAS

    Measured: up to 12 weeks

  5. Absolute differences to baseline in physicians global assessment of disease activity on a VAS

    Measured: up to 12 weeks

  6. Absolute differences to baseline in patient's assessment of physical function measured by a standardised Health Assessment Questionnaire (HAQ)

    Measured: up to 12 weeks

  7. Absolute differences to baseline in concentration of C-reactive protein (CRP)

    Measured: up to 12 weeks

  8. Absolute differences to baseline in erythrocyte sedimentation rate (ESR)

    Measured: up to 12 weeks

  9. Number of responders to ACR 50

    Measured: after 12 weeks of treatment

  10. Number of responders to ACR 70

    Measured: after 12 weeks of treatment

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

    Measured: after 12 weeks of treatment

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

    Measured: after 12 weeks of treatment

  13. Number of patients with adverse Events (AE)

    Measured: up to 12 weeks after first drug administration

  14. Number of patients with clinically relevant changes in laboratory tests

    Measured: up to 12 weeks after first drug administration

  15. Number of patients with clinically relevant changes in electrocardiogram (ECG)

    Measured: up to 12 weeks after first drug administration

  16. Number of patients with clinically relevant changes in vital signs

    Measured: up to 12 weeks after first drug administration

  17. Number of withdrawals due to AEs

    Measured: up to 12 weeks after first drug administration

  18. Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)

    Measured: up to 24 hours after last drug administration

  19. AUC0-t,ss (area under the drug plasma concentration-time curve over a dosing interval (t) at steady state

    Measured: up to 24 hours after last drug administration

  20. Cpre (predose concentration of the analyte in Plasma)

    Measured: up to 24 hours after last drug administration

  21. Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state)

    Measured: up to 24 hours after last drug administration

Timeline

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

  1. First posted13 Aug 2014 (estimated)
  2. Study startMay 2003
  3. Primary completionJan 2004

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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02214888
Sponsor's protocol ID
1175.18
Status last verified
Aug 2014
First submitted
12 Aug 2014
Last updated
13 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIRB 796 BS, low dose and BIRB 796 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 10 inclusion and 32 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: stopped early, as of the sponsor's last update on 13 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. 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 was stopped early. Results are not available in the source record.

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?

Number of responders according to the American College of Rheumatology (ACR) 20 criteria (time frame: after 12 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 NCT02214888.

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 13 Aug 2014.

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