NCT02209779

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

August 5, 2014

Last Update Submit

August 5, 2014

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

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

    before and after 4 weeks of treatment

Secondary Outcomes (16)

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

    before and after 4 weeks of treatment

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

    before and after 4 weeks of treatment

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

    up to 57 days

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

    up to 57 days

  • Physicians global assessment of disease activity on a VAS

    up to 57 days

  • +11 more secondary outcomes

Study Arms (5)

BIBR 796 BS, low dose

EXPERIMENTAL

twice daily doses of 5 mg for 4 weeks

Drug: BIBR 796 BSDrug: Placebo

BIBR 796 BS, medium dose 1

EXPERIMENTAL

twice daily doses of 10 mg for 4 weeks

Drug: BIBR 796 BSDrug: Placebo

BIBR 796 BS, medium dose 2

EXPERIMENTAL

twice daily doses of 20 mg for 4 weeks

Drug: BIBR 796 BSDrug: Placebo

BIBR 796 BS, high dose

EXPERIMENTAL

twice daily doses of 30 mg for 4 weeks

Drug: BIBR 796 BS

Placebo

ACTIVE COMPARATOR
Drug: Placebo

Interventions

BIBR 796 BSDRUG
BIBR 796 BS, high doseBIBR 796 BS, low doseBIBR 796 BS, medium dose 1BIBR 796 BS, medium dose 2
PlaceboDRUG
BIBR 796 BS, low doseBIBR 796 BS, medium dose 1BIBR 796 BS, medium dose 2Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female from 18 to 75 years of age
  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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 5, 2014

First Posted

August 6, 2014

Study Start

May 1, 2001

Primary Completion

June 1, 2002

Last Updated

August 6, 2014

Record last verified: 2014-08