Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab
- Registration Number
- NCT03557853
- Lead Sponsor
- MSD Pharmaceuticals LLC
- Brief 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. 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Golimumab injection Golimumab Injection Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label.
- Primary Outcome Measures
Name Time Method BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up 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.
- Secondary Outcome Measures
Name Time Method BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up From baseline to 24 months 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.
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up From baseline to 24 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.
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up From baseline to 12 months 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.
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up From baseline to 12 months 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.
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up From baseline to 24 months 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.
BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up From baseline to 12 months 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).
BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up From baseline to 24 months 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).
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up From baseline to 24 months 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.BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up From baseline to 12 months 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.
Trial Locations
- Locations (6)
Moscow Clinical Scientific Center
🇷🇺Moscow, Russian Federation
KhMAO Regional Clinical Hospital
🇷🇺Khanty-Mansiysk, Russian Federation
Rheumatology Research Institute
🇷🇺Moscow, Russian Federation
Pirogov National Medical Surgical Center
🇷🇺Moscow, Russian Federation
Regional Clinical Hospital #2
🇷🇺Rostov-on-Don, Russian Federation
City Clinical Hospital
🇷🇺Yakutsk, Russian Federation