Spondylitis, AnkylosingPhase 4EUSpANCT00686894
Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440)
A Phase 4 study testing PDUS and Infliximab in people with Spondylitis, Ankylosing and SpA, run by Merck Sharp & Dohme LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylitis, Ankylosing, SpA
- What is being tested?
- PDUS and Infliximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Has participated in a study within 3 months prior to inclusion.
- Had treatment with unstable doses of analgesic drugs (paracetamol, phenylbutazone, morphine) steroid, NSAID, or immunosuppressive agent, including methotrexate, within 4 weeks prior to inclusion.
- Had Intra articular steroid within 4 weeks prior to inclusion.
- 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 :
- Infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g. bronchectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremeting cystitis) open, draining or infected skin wound, or ulcer. Serious infection(s) (such as hepatitis, pneumonia or pyelonephritis) within 3 months prior to inclusion.
- Malignancy within the previous 5 years with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence.
- Active tuberculosis or previous history of non treated or insufficiently treated tuberculosis.
- Patients with a positive intradermal tuberculosis test according to the local recommendation
- For the patients who could have been in contact with a person having tuberculosis, the inclusion will be possible under specific conditions depending of local recommendations issued in France, Denmark, Hungary, Italy, Spain.
- Herpes zoster (shingles) infection within 2 months prior to the first infusion
- Opportunistic infections, e.g. cytomegalovirus, Pneumocystis carinii pneumonia, aspergillosis, histoplasmosis or atypical mycobacterium infection.
- Has any of the following clinical conditions:
- Severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatic or cerebral diseases
- Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Known lymphoproliferative disease, including lymphoma, or signs suggestive of lymphoproliferative disease, such as lymphadenoma of unusual size and localization or splenomegaly.
- Have received live (attenuated) vaccination during the last 30 days
- Have been treated with a monoclonal antibody or a fusion protein except etanercept, adalimumab or any other anti TNF agent
- Leukopenia < 3,500/mm^3, Hemoglobin < 9g/dl, thrombopenia < 100,000/mm^3.
- Congestive heart failure (CHF) including medically controlled, asymptomatic CHF or unstable hemodynamic cardiac conditions.
- Scheduled surgical intervention at any time during the study.
- Multiple sclerosis or symptomatic demyelination of central nervous system.
- Subjects who have an history of drug abuse or alcoholism
About this study
Official title: Study of Peripheral Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab
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
- Being tested
- PDUS, Infliximab
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDUSProcedure or surgery
PDUS scored for each enthesitis every 2 weeks for 24 weeks.
InfliximabDrug
Also called SCH 215596, REMICADE
- 5 mg/kg
- IV
- Frequency : weeks 0,2,6
| Study group | Role | What they receive |
|---|---|---|
| Infliximab 5 mg/kg | Experimental | Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6. Receives: Procedure: PDUS; Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Poor Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686894
- Sponsor's protocol ID
- P04440
- Other IDs
- 2006-001579-40
- Acronym
- EUSpA
- Status last verified
- Jan 2017
- First submitted
- 27 May 2008
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Peripheral Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab
- ClinicalTrials.gov ID
- NCT00686894
- Acronym / sponsor ID
- EUSpA / P04440
- Conditions
- Spondylitis, Ankylosing, SpA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 5 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab 5 mg/kg | Experimental | Procedure: PDUS, Drug: InfliximabInfliximab infusions: 5 mg/kg at weeks 0, 2, and 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (36 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDUSPDUS scored for each enthesitis every 2 weeks for 24 weeks. | Procedure or surgery | Infliximab 5 mg/kg |
| InfliximabAlso: SCH 215596, REMICADE* 5 mg/kg * IV * Frequency : weeks 0,2,6 | Drug | Infliximab 5 mg/kg |
Primary outcome
The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PDUS and Infliximab in people with Spondylitis, Ankylosing and SpA, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.