Spondylitis, AnkylosingRECOVERYNCT02293681
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
An observational study of Spondylitis, Ankylosing, run by Janssen Research & Development, LLC at 6 sites in China.
Trial summary
The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Infliximab, NSAIDs and DMARDs
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 6 sitesChina
- Study dates
- 10 Apr 2015to 31 May 2017
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants suffering from ankylosing spondylitis with hip involvement.
Who may be able to join
- Diagnosed with ankylosing spondylitis (AS) (according to the modified New York Criteria for AS) at least 3 months prior to the Day 1 in the Follow-up I phase with symptoms of active disease atScreening/Baseline
- Hip pain and duration of hip symptom less than 2 years
- Harris hip score less than (<) 70
- Hip involvement proven by Magnetic resonance imaging (MRI)
- Being treated with infliximab and conventional therapy for 2 weeks to 6 months
Who cannot join
- Participant has a history of hip joint disability which was considered irreversible
- Participant has a history of hip joint replacement
- Participant has a history of treatment with biologics other than infliximab less than 6 months prior to study entry
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Study site
Beijing
Study site
Changsha
Study site
Chengdu
Study site
Guangzhou
Study site
Shanghai
Study site
Xi'an
About this study
Official title: A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment points) participants with hip involvement.
Read the detailed description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), observational study to compare the effectiveness of infliximab with conventional therapies in ankylosing spondylitis participants with hip joint involvement. The study will be conducted in 3 parts: a 14-day screening, a 30-week first follow-up (Follow-up 1), and an additional 22-week follow-up (Follow-up 2) up to Week 52. Participants will be assigned to two groups based on the current treatments they are receiving: cohort 1 participants receiving infliximab with or without combination of disease modifying drugs (DMARDs-such as Sulfasalazine, Methotrexate and Thalidomide) and/or non-steroidal anti-inflammatory drugs (NSAIDs) and in cohort 2 who are receiving DMARDs and/or NSAIDs for treatment of pain will be observed. Participants will primarily be assessed for change in harris hip score. Participants' safety will be monitored throughout the study.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Infliximab, NSAIDs, DMARDs
- Keywords
- Spondylitis, Ankylosing, Infliximab, Non-steroidal anti-inflammatory drugs, Disease-modifying anti-rheumatic drugs
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.
NSAIDsDrug
This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.
DMARDsDrug
This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Infliximab and/or NSAIDs and DMRADs | Participants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed. Receives: Drug: Infliximab; Drug: NSAIDs; Drug: DMARDs | |
| Cohort 2: NSAIDs and DMARDs | Participants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed. Receives: Drug: NSAIDs; Drug: DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Harris Hip Score at Week 30
Harris hip score, a physician-assessed scoring method consisting of 10 items: pain, limp, support, distance walked, sitting, enter public transportation, stairs, put on shoes and socks, absence of deformity and range of motion. The scoring system covers domains like pain, function, absence of deformity and range of motion. The total Harris hip score has a maximum of 100 points with a higher score indicating a better hip function: Excellent (90-100), Good (80-89), Fair (70-79) and Poor (<70).
Measured: Baseline and Week 30
Secondary outcomes (6)
Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10cm visual analog scale (VAS), with 1 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom.
Measured: Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52
The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. Higher BASFI score indicates more severe functional limitations of the participant due to AS.
Measured: Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52
The BASMI is an accurate and reproducible metrology index developed to assess the clinical changes in spinal movements of AS participants. This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall, lumbar flexion (modified Schober's), intermalleoar distance and cervical rotation. The potential scores for each measurement are 0, 1, and 2, indicating a disease severity of mild, moderate and severe, respectively. A higher BASMI score indicates a more severe movement limitation due to AS.
Measured: Baseline, Week 30 and 52
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52
The ASDAS is composite score based on the calculation of 5 disease activities: 4 are participant's reported outcomes (back pain, duration of morning stiffness, participant global and peripheral pain/swelling) and one serologic inflammation marker (creatinine reactive protein - CRP). The score is the sum of the 5 items with different specified weights, with a minimum of 0 and no upper limit. Thus this index can reflect both long term disease activity and acute phase status. There are 3 cut-offs in score to show: a) the 4 states of disease activity: inactive disease (<1.3), moderate disease activity (1.3-2.1), high disease activity (2.1-3.5) and very high disease activity (>3.5). b) effectiveness of the treatment, two validated cut-offs were developed: a change of 1.1-2.0 (clinically important improvement) and a change >2.0 (major improvement).
Measured: Baseline, Week 30 and 52
Change From Baseline in Harris Hip Score at Week 14 and 52
Harris hip score, a physician-assessed scoring method consisting of 10 items: pain, limp, support, distance walked, sitting, enter public transportation, stairs, put on shoes and socks, absence of deformity and range of motion. The scoring system covers domains like pain, function, absence of deformity and range of motion. The total Harris hip score has a maximum of 100 points with a higher score indicating a better hip function: Excellent (90-100), Good (80-89), Fair (70-79) and Poor (<70).
Measured: Baseline, Week 14 and 52
Assessment of Improvement in Hip Joint
Radiological improvements of hip joint will be assessed using magnetic resonance imaging (MRI) and X-ray examinations.
Measured: Baseline, Week 30 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study start10 Apr 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Why it stopped: The project was stopped by 31-May-2017 because of internal owner decision from out of balance enrollment from two groups.
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 Janssen Research & Development, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293681
- Sponsor's protocol ID
- CR104999
- Other IDs
- REMICADEAKS4006
- Acronym
- RECOVERY
- Status last verified
- Oct 2017
- First submitted
- 14 Nov 2014
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
- ClinicalTrials.gov ID
- NCT02293681
- Acronym / sponsor ID
- RECOVERY / CR104999
- Conditions
- Spondylitis, Ankylosing
- Keywords
- Spondylitis, Ankylosing, Infliximab, Non-steroidal anti-inflammatory drugs, Disease-modifying anti-rheumatic drugs
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The project was stopped by 31-May-2017 because of internal owner decision from out of balance enrollment from two groups.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 18 Nov 2014 (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 purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment points) participants with hip involvement.
Detailed description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), observational study to compare the effectiveness of infliximab with conventional therapies in ankylosing spondylitis participants with hip joint involvement. The study will be conducted in 3 parts: a 14-day screening, a 30-week first follow-up (Follow-up 1), and an additional 22-week follow-up (Follow-up 2) up to Week 52. Participants will be assigned to two groups based on the current treatments they are receiving: cohort 1 participants receiving infliximab with or without combination of disease modifying drugs (DMARDs-such as Sulfasalazine, Methotrexate and Thalidomide) and/or non-steroidal anti-inflammatory drugs (NSAIDs) and in cohort 2 who are receiving DMARDs and/or NSAIDs for treatment of pain will be observed. Participants will primarily be assessed for change in harris hip score. Participants' safety will be monitored throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Infliximab and/or NSAIDs and DMRADs | – | Drug: Infliximab, Drug: NSAIDs, Drug: DMARDsParticipants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed. |
| Cohort 2: NSAIDs and DMARDs | – | Drug: NSAIDs, Drug: DMARDsParticipants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants suffering from ankylosing spondylitis with hip involvement.
Key inclusion criteria (5 listed)
- Diagnosed with ankylosing spondylitis (AS) (according to the modified New York Criteria for AS) at least 3 months prior to the Day 1 in the Follow-up I phase with symptoms of active disease atScreening/Baseline
- Hip pain and duration of hip symptom less than 2 years
- Harris hip score less than (<) 70
- Hip involvement proven by Magnetic resonance imaging (MRI)
- Being treated with infliximab and conventional therapy for 2 weeks to 6 months
Key exclusion criteria (3 listed)
- Participant has a history of hip joint disability which was considered irreversible
- Participant has a history of hip joint replacement
- Participant has a history of treatment with biologics other than infliximab less than 6 months prior to study entry
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 |
|---|---|---|
| InfliximabThis is an observational study. Participants receiving intravenous infusion of infliximab will be observed. | Drug | Cohort 1: Infliximab and/or NSAIDs and DMRADs |
| NSAIDsThis is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed. | Drug | Cohort 1: Infliximab and/or NSAIDs and DMRADs, Cohort 2: NSAIDs and DMARDs |
| DMARDsThis is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed. | Drug | Cohort 1: Infliximab and/or NSAIDs and DMRADs, Cohort 2: NSAIDs and DMARDs |
Primary outcome
Change From Baseline in Harris Hip Score at Week 30
Time frame: Baseline and Week 30
Harris hip score, a physician-assessed scoring method consisting of 10 items: pain, limp, support, distance walked, sitting, enter public transportation, stairs, put on shoes and socks, absence of deformity and range of motion. The scoring system covers domains like pain, function, absence of deformity and range of motion. The total Harris hip score has a maximum of 100 points with a higher score indicating a better hip function: Excellent (90-100), Good (80-89), Fair (70-79) and Poor (<70).
6 secondary outcomes
Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52
Time frame: Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52
Time frame: Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52
Time frame: Baseline, Week 30 and 52
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52
Time frame: Baseline, Week 30 and 52
Change From Baseline in Harris Hip Score at Week 14 and 52
Time frame: Baseline, Week 14 and 52
Assessment of Improvement in Hip Joint
Time frame: Baseline, Week 30 and 52
Results and safety
The study was stopped early (reason given: The project was stopped by 31-May-2017 because of internal owner decision from out of balance enrollment from two groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylitis, Ankylosing, run by Janssen Research & Development, LLC at 6 sites in China.
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 5 inclusion and 3 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: The project was stopped by 31-May-2017 because of internal owner decision from out of balance enrollment from two groups.). Results are not available in the source record.
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?
Change From Baseline in Harris Hip Score at Week 30 (time frame: Baseline and Week 30). 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 1 Nov 2017.