Spondylitis, AnkylosingPhase 4NCT00778869
Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)
A Phase 4 study testing Remicade in people with Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
Trial summary
This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to examine the expression profile of genes in patients in the active stage of ankylosing spondylitis (AS) compared to the healthy population as control, moreover to examine the changes in expression profile during anti-tumor… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Remicade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Aug 2005
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of ankylosing spondylitis proven by appropriate diagnostic methods (according to New York criteria).
- Refractory disease defined by failure of at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) during a 3-month period and failure of sulfasalazine in subjects with associated peripheral arthritis.
- Active disease defined by:
- sustained bath ankylosing spondylitis disease activity index (BASDAI) of at least 40 on a 0-100 scale and
- expert opinion based on clinical features.
- Age between 18 and 70 years.
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- Subjects using NSAIDs and/or sulfasalazine must have been on a stable dose for at least 4 weeks prior to study initiation, and may continue medication during the treatment period, but the dose must not be increased above the baseline.
- Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Men and women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed intrauterine device (IUD), condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
- Subjects must understand and be able to adhere to the dosing and visit schedules.
Who cannot join
- Subject with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Remicade must not be given to subjects with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
- Subjects with pre-existing or recent onset of central nervous system demyelinating disorders.
- Age <18 or >70 years.
- Pregnant women, nursing mothers.
- Subjects who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
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- Subjects who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab therapy.
- Prior administration of infliximab or any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) (eg, Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody).
- Current treatment with systemic corticosteroid.
- Treatment with any investigational drug within the previous 3 months.
- History of known allergies to murine proteins.
- Subjects having active or inactive tuberculosis (TB). All subjects must be evaluated for both active and inactive ('latent') TB. This evaluation should include a detailed medical history with personal history of TB or possible previous contact with TB and previous and/or current immunosuppressive therapy. Appropriate screening tests (ie, tuberculin skin test and chest x-ray) should be performed in all subjects.
- Serious infection, such as sepsis, abscesses, hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the treating physician.
- History of opportunistic infections such as herpes zoster within 2 months of study initiation. Evidence of active cytomegalovirus (CMV), active pneumocystis carinii, drug resistant atypical mycobacterium, etc.
- Documented human immunodeficiency virus (HIV) infection.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past 5 years (except non-melanoma skin cancer and surgically cured cervical cancer).
- Subjects with alcoholism, alcoholic liver disease, or other chronic liver disease.
About this study
Official title: Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment Compared to Healthy Controls
This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to examine the expression profile of genes in patients in the active stage of ankylosing spondylitis (AS) compared to the healthy population as control, moreover to examine the changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment (Remicade).
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Remicade
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemicadeBiological
Also called Infliximab, SCH 215596
Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
| Study group | Role | What they receive |
|---|---|---|
| Remicade | Experimental | Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. Receives: Biological: Remicade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Genes Which Were Differentially Expressed
Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startAug 2005
- Primary completionAug 2005
- Study completionAug 2005
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778869
- Sponsor's protocol ID
- P04465
- Status last verified
- Jun 2015
- First submitted
- 23 Oct 2008
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT00778869
- Acronym / sponsor ID
- P04465
- Conditions
- Spondylitis, Ankylosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 9 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to examine the expression profile of genes in patients in the active stage of ankylosing spondylitis (AS) compared to the healthy population as control, moreover to examine the changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment (Remicade).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remicade | Experimental | Biological: RemicadeRemicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ankylosing spondylitis proven by appropriate diagnostic methods (according to New York criteria).
- Refractory disease defined by failure of at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) during a 3-month period and failure of sulfasalazine in subjects with associated peripheral arthritis.
- Active disease defined by:
- Age between 18 and 70 years.
- Subjects using NSAIDs and/or sulfasalazine must have been on a stable dose for at least 4 weeks prior to study initiation, and may continue medication during the treatment period, but the dose must not be increased above the baseline.
Key exclusion criteria (18 listed)
- Subject with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Remicade must not be given to subjects with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
- Subjects with pre-existing or recent onset of central nervous system demyelinating disorders.
- Age <18 or >70 years.
- Pregnant women, nursing mothers.
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 |
|---|---|---|
| RemicadeAlso: Infliximab, SCH 215596Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. | Biological | Remicade |
Primary outcome
Number of Genes Which Were Differentially Expressed
Time frame: 14 weeks
Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Remicade in people with Spondylitis, Ankylosing, 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 3 Jul 2015. 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 9 Apr 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?
Number of Genes Which Were Differentially Expressed (time frame: 14 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 3 Jul 2015.