Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440)

NCT00686894 | Terminated Phase 4 Results

• 2 other identifiers: P044402006-001579-40
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6. Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in subjects treated with infliximab.

Conditions

Spondylitis, Ankylosing; SpA

Outcome Measures

Primary Outcomes (1)

• The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.

  Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm\^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.

  8 weeks

Study Arms (1)

Infliximab 5 mg/kg

EXPERIMENTAL

Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.

Procedure: PDUS; Drug: Infliximab

Interventions

PDUS PROCEDURE

PDUS scored for each enthesitis every 2 weeks for 24 weeks.

Infliximab 5 mg/kg

Infliximab DRUG

* 5 mg/kg * IV * Frequency : weeks 0,2,6

Also known as: SCH 215596, REMICADE

Infliximab 5 mg/kg

Eligibility Criteria

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

You may qualify if:

• Demonstrate willingness to participate in study, adhere to dose and visit schedules, and comply with procedures by signing a written informed consent.
• Negative serum pregnancy test at Week 0.
• Men and women over 18 years of either sex and any race.
• Free of any clinically relevant disease other than SpA that would in the principal investigator's and/or sponsor's opinion, interfere with the conduct of study or its evaluations.
• Eligible for anti-tumor necrosis factor (TNF) treatment according to applicable local guidelines.
• Fulfill the following criteria: European Spondyloarthropathy Study group (ESSG) Classification Criteria, and/or Amor Criteria, and/or New York modified criteria.
• Disease duration of SpA \>6 months.
• Incomplete response to non-steriodal anti-inflammatory drug (NSAID).
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>4 including item 2 (axial pain) \>=3 on a scale from 0 to 10.
• At least 1 enthesitis assessed by PDUS.
• C-reactive protein (CRP) twice upper normal laboratory value or inflammatory signal on magnetic resonance imaging (MRI) of spine or sacroiliac joint within the last 3 months.
• Practicing adequate contraception during the study and for 6 months after last infusion.
• Week 0 laboratory tests must meet protocol criteria.

You may not qualify if:

• Is a female who is pregnant, or intends to become pregnant during the study (or within 6 months after receiving the last infusion);
• Is a female who is nursing, or intends to be nursing during the study or within 6 month after having received the last infusion;
• Has childbearing potential without contraception throughout the study and for 6 months after receiving the last infusion.
• Has not observed the designated washout periods for any of the prohibited medications outlined in the protocol;
• Has any clinically significant deviation from the appropriate reference range in the physical examination, Chest X-ray, that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety;
• Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
• Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study;
• Is allergic to or has sensitivity to the study drug or its excipients;
• Has intolerance to or contraindication for infliximab.
• Has an history of allergy to murine products.
• Is uncooperative or has not signed the consent form.
• Cannot understand the protocol.
• Had Previous treatment with infliximab
• Had previous treatment with etanercept, adalimumab or any other TNF agent within 2 last months.
• Had an history of, ongoing or recurrent medical condition as follows :

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 13, 2017
• Results First Posted: March 5, 2010

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share