Ankylosing SpondylitisGO-COXNCT03557853
Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab
An observational study of Ankylosing Spondylitis and Coxitis, run by MSD Pharmaceuticals LLC at 6 sites in Russia.
Trial summary
Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited. Primary objective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Coxitis
- What is being tested?
- Golimumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 6 sitesRussia
- Study dates
- Jun 2016to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Patients with ankylosing spondylitis and coxitis followed in normal practice, in whom golimumab has been newly prescribed.
Who may be able to join
- Adult patients (>18 years of age) with definite AS (as per modified New York criteria)
- Coxitis with BASRI-hip score 0-2
- Newly prescribed golimumab according to usual clinical practice
- Naïve to anti-TNFs or other biologic agents prior to initiation of golimumab as indicated by the patient's medical records
- Patient is enrolled after the investigator's decision to treat with golimumab, but before initiation of treatment with golimumab
- Patient was informed of the benefits and risks of golimumab as per normal practice using the product leaflet
- Signed informed consent form
Who cannot join
- Any contraindication to golimumab in accordance to the label of Simponi®
- BASRI-hip score 3-4
- Any contraindication to MRI, e.g. previous hip joint replacement, heart pace maker.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
KhMAO Regional Clinical Hospital
Khanty-Mansiysk
Moscow Clinical Scientific Center
Moscow
Pirogov National Medical Surgical Center
Moscow
Rheumatology Research Institute
Moscow
Regional Clinical Hospital #2
Rostov-on-Don
City Clinical Hospital
Yakutsk
About this study
Official title: A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)
Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited.
Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice
Read more
Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia.
Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice.
Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N.
Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) -2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.
- Conditions
- Ankylosing Spondylitis, Coxitis
- Being tested
- Golimumab Injection
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab InjectionDrug
Also called Based on decision of investigators.
Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab injection | Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Receives: Drug: Golimumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up
The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
Measured: From baseline to 12 months
Secondary outcomes (9)
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up
The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
Measured: From baseline to 24 months
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.
Measured: From baseline to 12 months
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.
Measured: From baseline to 24 months
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up
The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP.
Measured: From baseline to 12 months
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up
The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP.
Measured: From baseline to 24 months
BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up
The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours).
Measured: From baseline to 12 months
BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up
The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours).
Measured: From baseline to 24 months
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up
The BASRI-hip is a score of structural impairment of hip on X-ray images:
0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm.
Measured: From baseline to 12 months
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up
The BASRI-hip is a score of structural impairment of hip on X-ray images:
0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm.
Measured: From baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJun 2016
- Primary completionJul 2018
- Study completion30 Jun 2021
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 Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSD Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekaterina Lukyanova, MD, Study director, MSD Pharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557853
- Sponsor's protocol ID
- MK-8259-021
- Acronym
- GO-COX
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2018
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)
- ClinicalTrials.gov ID
- NCT03557853
- Acronym / sponsor ID
- GO-COX / MK-8259-021
- Conditions
- Ankylosing Spondylitis, Coxitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- MSD Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited.
Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice
Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia.
Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice.
Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N.
Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) -2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab injection | – | Drug: Golimumab InjectionPatients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankylosing spondylitis and coxitis followed in normal practice, in whom golimumab has been newly prescribed.
Key inclusion criteria (7 listed)
- Adult patients (>18 years of age) with definite AS (as per modified New York criteria)
- Coxitis with BASRI-hip score 0-2
- Newly prescribed golimumab according to usual clinical practice
- Naïve to anti-TNFs or other biologic agents prior to initiation of golimumab as indicated by the patient's medical records
- Patient is enrolled after the investigator's decision to treat with golimumab, but before initiation of treatment with golimumab
Key exclusion criteria (3 listed)
- Any contraindication to golimumab in accordance to the label of Simponi®
- BASRI-hip score 3-4
- Any contraindication to MRI, e.g. previous hip joint replacement, heart pace maker.
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 |
|---|---|---|
| Golimumab InjectionAlso: Based on decision of investigators.Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice. | Drug | Golimumab injection |
Primary outcome
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up
Time frame: From baseline to 12 months
The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
9 secondary outcomes
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up
Time frame: From baseline to 24 months
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up
Time frame: From baseline to 12 months
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up
Time frame: From baseline to 24 months
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up
Time frame: From baseline to 12 months
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up
Time frame: From baseline to 24 months
BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up
Time frame: From baseline to 12 months
BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up
Time frame: From baseline to 24 months
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up
Time frame: From baseline to 12 months
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up
Time frame: From baseline to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
Ekaterina Lukyanova, MD study director
MSD Pharmaceuticals 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 Ankylosing Spondylitis and Coxitis, run by MSD Pharmaceuticals LLC at 6 sites in Russia.
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 7 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: finished, as of the sponsor's last update on 15 Aug 2024. 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 Russia. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2024). 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?
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up (time frame: From baseline to 12 months). 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 15 Aug 2024.