Spondylitis, AnkylosingPhase 4NCT00779935
Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)
A Phase 4 study testing Remicade in people with Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
Trial summary
This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20 clinical response at Week 14 will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- 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
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2004to 1 Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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 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 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 (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 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 CMV, active pneumocystis carinii, drug resistant atypical mycobacterium, etc.
- Documented 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: Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot Study
This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20 clinical response at Week 14 will be evaluated.
- 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.
To investigate whether baseline serum VEGF concentration predicts ASAS-20 clinical response to infliximab at Week 14.
Measured: Week 14
Secondary outcomes (4)
To detect clinical response rates at Weeks 2, 6, 14, 30, 54, and at Follow-up Visit 2, which is 6 months after completion of study treatment.
Measured: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To measure the duration of response
Measured: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To detect the percent of patients reaching partial response
Measured: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To measure the duration of partial response
Measured: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
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 start1 Oct 2004
- Primary completion1 Oct 2005
- Study completion1 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 44 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
- NCT00779935
- Sponsor's protocol ID
- P04041
- Status last verified
- May 2017
- First submitted
- 23 Oct 2008
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot Study
- ClinicalTrials.gov ID
- NCT00779935
- Acronym / sponsor ID
- P04041
- Conditions
- Spondylitis, Ankylosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2004 (actual)
- Primary completion
- 1 Oct 2005 (actual)
- Study completion
- 1 Feb 2007 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20 clinical response at Week 14 will be evaluated.
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
- Not 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 (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
To investigate whether baseline serum VEGF concentration predicts ASAS-20 clinical response to infliximab at Week 14.
Time frame: Week 14
4 secondary outcomes
To detect clinical response rates at Weeks 2, 6, 14, 30, 54, and at Follow-up Visit 2, which is 6 months after completion of study treatment.
Time frame: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To measure the duration of response
Time frame: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To detect the percent of patients reaching partial response
Time frame: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
To measure the duration of partial response
Time frame: Weeks 2, 6, 14, 30, 54 and 6 months afterwards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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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 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate whether baseline serum VEGF concentration predicts ASAS-20 clinical response to infliximab at Week 14. (time frame: Week 14). 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 11 May 2017.