Spondylitis, AnkylosingPhase 4NCT00779012
A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)
A Phase 4 study testing Infliximab in people with Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6… 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?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2004to 1 Jun 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
- Patients 18 to 70 years of age.
- Males and female patients of reproductive potential (also includes women who have been postmenopaused <1 year) must use a reliable birth control method (abstinence, oral contraceptives, diaphragm prescribed by a physician, condom used with a spermicide, surgical sterilization) up until 6 months after the last Remicade infusion.
- Proven AS according to the modified New York criteria implying that included patients must have a pelvic x-ray showing the signs of sacroiliitis > grade 2 bilateral.
- Acute phase of disease during not less than last 3 months under condition of the everyday intake of some of NSAIDs in full daily dosage for at least 1 month before the initiation of the treatment, significant spinal pain (VAS > 4)during the last week prior to the inclusion into the study. In case of peripheral joints arthritis besides the measures mentioned above the absence of the efficacy of at least 2-times intraarticular injection of steroids (if only it is not contraindicated or not well tolerated) or sulfasalazine intake at a daily dose of 2-3 g for at least 4 months (if only it is not contraindicated or not well tolerated) should be established. In case of enthesitis inflammation besides the measures mentioned above the absence of the efficacy of at least 2-times local injection of steroids (if only it is not contraindicated or not well tolerated) should be established.
- Ability to comprehend the terms of the participation in the study, willing to follow all procedures and instructions and informed consent form signed before the beginning of the first procedures of the study (except several cases of chest x-ray).
- Screening for prevention of latent and active TB must be performed according to the local guidelines and/or the current SPC and alert card. This will include a PPD test and a Chest x-ray to be performed within 30 days prior to initiating treatment with Remicade.
Who cannot join
- Pregnant women, nursing mothers or a planned pregnancy within 6 months after the last infusion.
- Patients who have any concurrent systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from Remicade, e.g. Lyme disease, or a rheumatic disease (lupus erythematosus, systemic scleroderma) with the joint affection and sacroileitis.
- Prior administration of Remicade or any other therapeutic agent targeted at reducing TNF (e.g.,Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 3 months.
- History of known allergies to murine proteins.
- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the treating physician.
- Any chronic infections in the acute phase, e.g. upper respiratory tract infections or other localization (chronic bronchitis, pneumonia, pyelonephritis, cholecystitis, hepatitis etc.).
Show all 18Show fewer
- Documented HIV infection.
- Positive hepatitis B and C test without clinical signs of the disease.
- Current skin psoriasis, nonspecific ulcerative colitis and Crohn's disease.
- History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium infections, etc.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, 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.
- Active and/or latent TB or previous history of TB.
- Non-stable doses of the basic steroid therapy or NSAID therapy within 4 weeks before the inclusion into the study.
- Supportive prednisone therapy >10 mg/day.
- Patients with moderate or severe heart failure (NYHA class III/IV).
- Septic arthritis (or infected joint implant) within at least last 12 months.
- Necessity in the use of other medicinal products.
About this study
Official title: Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing Spondylitis
The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
- Conditions
- Spondylitis, Ankylosing
- Being tested
- 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.
InfliximabBiological
Also called Remicade, SCH 215596
Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
| Study group | Role | What they receive |
|---|---|---|
| Remicade | Experimental | Not described Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy and safety rate of the study drug, Remicade, in decreasing symptoms and signs of AS (pain) as well as the evaluation of the safety and the tolerance of the profile of the drug.
Measured: The patient undergoes the complex evaluation of the articular status every 6 -8 weeks.
Secondary outcomes (18)
Frequency of achievement of at least 50% ASAS improvement (compared to baseline) 8 weeks after the last infusion of Remicade.
Measured: 8 weeks after the last infusion of Remicade
Frequency of at least 50% of the stable improvement of ASAS (compared to baseline) over a period of the supportive treatment phase (after infusion 3, up to 6 to 8 weeks after the last infusion of Remicade)
Measured: Up to 8 weeks after the last infusion of Remicade
Frequency of at least 20%, 50%, and 75% of ASAS improvement (compared to baseline) 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change in AS activity (BASDAI) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of global evaluation of the activity of the disease by patient (VAS) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the functional status of the patients (BASFI) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of spine motion compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of spinal pain compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of sensation of fatigue compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Measured: Up to 8 weeks after the last infusion of Remicade
Change of pain in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the duration of the morning stiffness in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the number of tender joints compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the number of inflamed joints compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the number of the transformed enthesitises compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of the duration of the morning spinal stiffness compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Change of serum C-reactive protein and ESR compared to baseline 6 to 8 weeks after the last infusion of Remicade
Measured: Up to 8 weeks after the last infusion of Remicade
Quality of life evaluation in accordance with SF-36
Measured: 6-8 weeks after visit 10 (before the last infusion of Remicade) or in case of discontinuation
Obtaining of additional information on the safety profile of the tested product over a period of the study.
Measured: up to 54 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 start1 Oct 2004
- Primary completion1 Jun 2007
- Study completion1 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 42 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
- NCT00779012
- Sponsor's protocol ID
- P04042
- Status last verified
- May 2017
- First submitted
- 23 Oct 2008
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bunchuk NV, Rumiantseva OA, Loginova EIu, Bochkova AG, Storozhakov GI, Ettinger OA, Kosiura SD, Kamalova RG, Valishina LM. [The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study]. Ter Arkh. 2010;82(10):41-6. Russian.
PubMed 21341463
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
- Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00779012
- Acronym / sponsor ID
- P04042
- Conditions
- Spondylitis, Ankylosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2004 (actual)
- Primary completion
- 1 Jun 2007 (actual)
- Study completion
- 1 Jun 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.
The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).
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: Infliximab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 to 70 years of age.
- Males and female patients of reproductive potential (also includes women who have been postmenopaused <1 year) must use a reliable birth control method (abstinence, oral contraceptives, diaphragm prescribed by a physician, condom used with a spermicide, surgical sterilization) up until 6 months after the last Remicade infusion.
- Proven AS according to the modified New York criteria implying that included patients must have a pelvic x-ray showing the signs of sacroiliitis > grade 2 bilateral.
- Acute phase of disease during not less than last 3 months under condition of the everyday intake of some of NSAIDs in full daily dosage for at least 1 month before the initiation of the treatment, significant spinal pain (VAS > 4)during the last week prior to the inclusion into the study. In case of peripheral joints arthritis besides the measures mentioned above the absence of the efficacy of at least 2-times intraarticular injection of steroids (if only it is not contraindicated or not well tolerated) or sulfasalazine intake at a daily dose of 2-3 g for at least 4 months (if only it is not contraindicated or not well tolerated) should be established. In case of enthesitis inflammation besides the measures mentioned above the absence of the efficacy of at least 2-times local injection of steroids (if only it is not contraindicated or not well tolerated) should be established.
- Ability to comprehend the terms of the participation in the study, willing to follow all procedures and instructions and informed consent form signed before the beginning of the first procedures of the study (except several cases of chest x-ray).
Key exclusion criteria (18 listed)
- Pregnant women, nursing mothers or a planned pregnancy within 6 months after the last infusion.
- Patients who have any concurrent systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from Remicade, e.g. Lyme disease, or a rheumatic disease (lupus erythematosus, systemic scleroderma) with the joint affection and sacroileitis.
- Prior administration of Remicade or any other therapeutic agent targeted at reducing TNF (e.g.,Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 3 months.
- History of known allergies to murine proteins.
- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the treating physician.
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 |
|---|---|---|
| InfliximabAlso: Remicade, SCH 215596Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions). | Biological | Remicade |
Primary outcome
Evaluation of the efficacy and safety rate of the study drug, Remicade, in decreasing symptoms and signs of AS (pain) as well as the evaluation of the safety and the tolerance of the profile of the drug.
Time frame: The patient undergoes the complex evaluation of the articular status every 6 -8 weeks.
18 secondary outcomes
Frequency of achievement of at least 50% ASAS improvement (compared to baseline) 8 weeks after the last infusion of Remicade.
Time frame: 8 weeks after the last infusion of Remicade
Frequency of at least 50% of the stable improvement of ASAS (compared to baseline) over a period of the supportive treatment phase (after infusion 3, up to 6 to 8 weeks after the last infusion of Remicade)
Time frame: Up to 8 weeks after the last infusion of Remicade
Frequency of at least 20%, 50%, and 75% of ASAS improvement (compared to baseline) 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change in AS activity (BASDAI) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of global evaluation of the activity of the disease by patient (VAS) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the functional status of the patients (BASFI) compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of spine motion compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of spinal pain compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of sensation of fatigue compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of pain in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the duration of the morning stiffness in peripheral joints compared to baseline 6 to 8 weeks after the last infusion of Remicade (VAS)
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the number of tender joints compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the number of inflamed joints compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the number of the transformed enthesitises compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of the duration of the morning spinal stiffness compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Change of serum C-reactive protein and ESR compared to baseline 6 to 8 weeks after the last infusion of Remicade
Time frame: Up to 8 weeks after the last infusion of Remicade
Quality of life evaluation in accordance with SF-36
Time frame: 6-8 weeks after visit 10 (before the last infusion of Remicade) or in case of discontinuation
Obtaining of additional information on the safety profile of the tested product over a period of the study.
Time frame: up to 54 weeks
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.
- Results publication: PubMed 21341463Bunchuk NV, Rumiantseva OA, Loginova EIu, Bochkova AG, Storozhakov GI, Ettinger OA, Kosiura SD, Kamalova RG, Valishina LM. [The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study]. Ter Arkh. 2010;82(10):41-6. Russian.
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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 Infliximab 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 6 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?
Evaluation of the efficacy and safety rate of the study drug, Remicade, in decreasing symptoms and signs of AS (pain) as well as the evaluation of the safety and the tolerance of the profile of the drug. (time frame: The patient undergoes the complex evaluation of the articular status every 6 -8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779012, which also lists 1 linked publication.
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.