Phase 1 Completed N=14 Treatment

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT00361634 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcomePrimary: Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29 — 15.04 Percent change

Summary

The purpose of this study is to assess whether DCE-MRI can detect changes of active disease in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29	15.04	—
PRIMARY Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57	40.75	—
PRIMARY Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85	55.00	—
PRIMARY Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29	8.64	—
PRIMARY Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57	15.30	—
PRIMARY Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85	34.54	—
SECONDARY Percent Change in Synovial Volume From Days 1-29	-4.15	—
SECONDARY Percent Change in Synovial Volume From Days 1-57	-6.52	—
SECONDARY Percent Change in Synovial Volume From Days 1-85	7.75	—
SECONDARY Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29	-50.24	—
SECONDARY Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57	-49.96	—
SECONDARY Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85	-35.72	—
SECONDARY Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29	-5.96	—
SECONDARY Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57	-8.68	—
SECONDARY Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85	10.55	—

Eligibility Criteria

Inclusion Criteria

Fulfillment of the 1987 American College of Rheumatology (ACR) criteria for RA with a disease duration > 6 months
Presence of active disease (defined as both tender and swollen joints) in at least one wrist
Sub-optimal response to methotrexate (MTX) defined by the presence of the following criteria (based on 68/66 joint count): 8 or more swollen joints AND 8 or more tender joints (with involvement of the wrist, fingers and at least one region outside the hands) at screening
Must be receiving MTX at a stable dose > 15 mg/week at least 12 weeks prior to baseline
a lower dose is acceptable if otherwise not tolerated (toxicity documentation required).

Exclusion Criteria

Patients who are currently receiving disease modifying anti-rheumatic drug (DMARD) therapy (other than MTX, hydroxychloroquine or sulfasalazine) including tumor necrosis factor (TNF) antagonists (etanercept, infliximab, and adalimumab), abatacept, rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection) within 8 weeks or 5.5 half-lives, whichever is longer, of screening
Co-existing condition requiring medications that alter vascular flow (e.g., nitrates, calcium channel blockers, ergot containing drugs) [Potential effects of antihypertensive and migraine medications will be discussed with the Sponsor]
Comorbid autoimmune disorders including systemic lupus erythematosus
Unable to undergo an MRI examination (e.g., presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip or pedicle screws
allergic to contrast agent
tattoos [in area of examination if contains metallic pigment])
or will likely require sedation for the procedure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00361634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.