NCT00043732

Brief Summary

The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

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

First Submitted

Initial submission to the registry

August 12, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

August 12, 2002

Last Update Submit

April 26, 2010

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisScio-469

Outcome Measures

Primary Outcomes (1)

  • Assess the safety and tolerability of multiple oral doses of SCIO-469 in patients with active rheumatoid arthritis (RA) who were also receiving stable doses of methotrexate (MTX).

Secondary Outcomes (1)

  • To assess the efficacy of multiple oral doses of SCIO-469 using the American College of Rheumatology (ACR) response criteria. To determine the PK of multiple oral doses of SCIO-469 in patients with active RA who are also receiving MTX.

Interventions

SCIO-469DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who have active rheumatoid arthritis and are receiving methotrexate
  • meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis
  • has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .

You may not qualify if:

  • Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months
  • Had elevation of liver enzymes within past 6 months
  • Has a history of Tuberculosis
  • Vertigo, inner ear, or vestibular abnormalities
  • Cancer
  • HIV-positive
  • Abnormal electrocardiogram
  • patient has chronic or acute infection
  • Multiple sclerosis, neuropathy or encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

SCIO-469

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Scios, Inc. Clinical Trial

    Scios, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2002

First Posted

August 14, 2002

Study Completion

September 1, 2003

Last Updated

April 27, 2010

Record last verified: 2010-04