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

NCT02214888 | Terminated Phase 2

• 1 other identifier: 1175.18
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Number of responders according to the American College of Rheumatology (ACR) 20 criteria

  after 12 weeks of treatment

Secondary Outcomes (21)

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

  up to 12 weeks

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

  up to 12 weeks

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

  up to 12 weeks

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

  up to 12 weeks

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

  up to 12 weeks

Study Arms (3)

BIRB 796 BS, low dose

EXPERIMENTAL

Drug: BIRB 796 BS, low dose; Drug: Placebo

BIRB 796 BS, high dose

EXPERIMENTAL

Drug: BIRB 796 BS, high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIRB 796 BS, low dose DRUG

BIRB 796 BS, low dose

BIRB 796 BS, high dose DRUG

BIRB 796 BS, high dose

Placebo DRUG

BIRB 796 BS, low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

doramapimod

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: August 12, 2014
• First Posted: August 13, 2014
• Study Start: May 1, 2003
• Primary Completion: January 1, 2004
• Last Updated: August 13, 2014

Record last verified: 2014-08