Axial Spondyloarthritis
Conditions
Keywords
Ankylosing Spondylitis, Ustekinumab, Golimumab, STELARA
Brief summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.
Detailed description
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 52), and Safety Follow-up (up to 12 weeks). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg. The total duration of study will be up to 64 weeks. Participants will be primarily assessed for Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 24. Participants' safety will be monitored throughout the trial.
Interventions
DRUGPlacebo
Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.
Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.
Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.
DRUGGolimumab 50 mg
Participants who meet EE criteria (less than \[\<\] 10 percent \[%\] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met * Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to (\>=4) and a visual analog scale (VAS) score for total back pain of \>=4, each on a scale of 0 to 10 * Participants with elevated high sensitivity C-reactive protein (hsCRP) level of \>=0.300 milligram per deciliter (mg/dL) at screening * Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent * Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs. * Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population
Exclusion criteria
* Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease * Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration * Participants who have ever received golimumab * Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent * Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 | Week(W) 24 | ASAS 40 defined as improvement from baseline of greater than or equal to (\>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI(self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI(non responder imputation)\] (missing responses at post baseline visit imputed as non-responder). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Week 24 | 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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder). |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24 | Baseline and Week 24 | The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) 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. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24). |
| Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24 | Week 24 | ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\* duration of morning stiffness) + (0.579\*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder). |
| Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Baseline, Week 4, 8, 12, 16, 20 and 24 | Change from baseline in hsCRP was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). |
| Percentage of Participants Who Achieved an ASAS 20 Response at Week 24 | Week 24 | ASAS 20 defined as improvement from baseline of \>= 20% from baseline and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder). |
| Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 4, 8, 12, 16 and 20 | ASAS 40 defined as improvement from baseline \>= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder). |
| Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 4, 8, 12, 16 and 20 | ASAS 20 defined as improvement from baseline of \>= 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder). |
| Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 4, 8, 12, 16 and 20 | 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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder). |
| Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Baseline, Week 4, 8, 12, 16 and 20 | The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) 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. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24). |
| Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 4, 8, 12, 16 and 20 | ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\* duration of morning stiffness) + (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders). |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, Mexico, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 315 participants were randomized and treated (104 participants to placebo, 106 participants to ustekinumab 45 milligram (mg), and 105 participants to 90 mg).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. | 104 |
| Ustekinumab 45mg Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind. | 106 |
| Ustekinumab 90mg Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind. | 105 |
| Total | 315 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Site terminated by sponsor | 0 | 0 | 1 |
| Overall Study | Study discontinued by sponsor | 64 | 72 | 69 |
| Overall Study | Withdrawal by Subject | 15 | 7 | 10 |
Baseline characteristics
| Characteristic | Placebo | Ustekinumab 45mg | Ustekinumab 90mg | Total |
|---|---|---|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 11.72 | 41.4 years STANDARD_DEVIATION 11.33 | 41.5 years STANDARD_DEVIATION 11.02 | 41.2 years STANDARD_DEVIATION 11.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 14 Participants | 16 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 91 Participants | 88 Participants | 270 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants | 16 Participants | 14 Participants | 44 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 8 Participants | 10 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 6 Participants | 8 Participants | 22 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 77 Participants | 75 Participants | 73 Participants | 225 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 16 Participants | 14 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) White | 82 Participants | 84 Participants | 84 Participants | 250 Participants |
| Region of Enrollment ARGENTINA | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Region of Enrollment BELGIUM | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Region of Enrollment BRAZIL | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Region of Enrollment BULGARIA | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Region of Enrollment CANADA | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment CZECH REPUBLIC | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Region of Enrollment FRANCE | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment GERMANY | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Region of Enrollment HUNGARY | 4 Participants | 9 Participants | 6 Participants | 19 Participants |
| Region of Enrollment MEXICO | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
| Region of Enrollment POLAND | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Region of Enrollment PORTUGAL | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 19 Participants | 27 Participants | 23 Participants | 69 Participants |
| Region of Enrollment SOUTH KOREA | 6 Participants | 5 Participants | 3 Participants | 14 Participants |
| Region of Enrollment SPAIN | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Region of Enrollment TAIWAN | 8 Participants | 10 Participants | 11 Participants | 29 Participants |
| Region of Enrollment UKRAINE | 28 Participants | 16 Participants | 22 Participants | 66 Participants |
| Region of Enrollment UNITED KINGDOM | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Region of Enrollment UNITED STATES | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 24 Participants | 18 Participants | 13 Participants | 55 Participants |
| Sex: Female, Male Male | 80 Participants | 88 Participants | 92 Participants | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 21 | 0 / 21 | 0 / 22 | 0 / 106 | 0 / 21 | 0 / 105 | 0 / 20 |
| other Total, other adverse events | 19 / 104 | 0 / 21 | 2 / 21 | 1 / 22 | 19 / 106 | 7 / 21 | 18 / 105 | 10 / 20 |
| serious Total, serious adverse events | 1 / 104 | 2 / 21 | 0 / 21 | 1 / 22 | 3 / 106 | 1 / 21 | 6 / 105 | 1 / 20 |
Outcome results
Primary
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
ASAS 40 defined as improvement from baseline of greater than or equal to (\>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI(self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI(non responder imputation)\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week(W) 24
Population: Modified-FAS included FAS population, excluding who discontinued study agent prior to W24 due to trial termination,not had efficacy assessments at W24,but not excluding participants who met EE at W16/ had treatment failure prior to W24.Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 | 12.3 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 | 19.2 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 | 26.9 Percentage of participants |
Secondary
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) 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. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).
Time frame: Baseline, Week 4, 8, 12, 16 and 20
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 16 | -0.58 Units on a scale | Standard Deviation 2.053 |
| Placebo | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 12 | -0.73 Units on a scale | Standard Deviation 2.406 |
| Placebo | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 4 | -0.58 Units on a scale | Standard Deviation 1.571 |
| Placebo | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 8 | -0.66 Units on a scale | Standard Deviation 2.099 |
| Placebo | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 20 | -1.45 Units on a scale | Standard Deviation 2.353 |
| Ustekinumab 45mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 12 | -0.70 Units on a scale | Standard Deviation 2.38 |
| Ustekinumab 45mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 4 | -0.69 Units on a scale | Standard Deviation 1.662 |
| Ustekinumab 45mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 8 | -0.86 Units on a scale | Standard Deviation 2.01 |
| Ustekinumab 45mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 16 | -0.54 Units on a scale | Standard Deviation 2.491 |
| Ustekinumab 45mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 20 | -1.73 Units on a scale | Standard Deviation 2.564 |
| Ustekinumab 90mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 20 | -2.16 Units on a scale | Standard Deviation 2.14 |
| Ustekinumab 90mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 16 | -0.80 Units on a scale | Standard Deviation 2.574 |
| Ustekinumab 90mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 4 | -0.73 Units on a scale | Standard Deviation 1.915 |
| Ustekinumab 90mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 12 | -0.77 Units on a scale | Standard Deviation 2.459 |
| Ustekinumab 90mg | Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20 | Change at Week 8 | -1.02 Units on a scale | Standard Deviation 2.01 |
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) 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. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).
Time frame: Baseline and Week 24
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24 | -1.29 Units on a scale | Standard Deviation 2.219 |
| Ustekinumab 45mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24 | -1.74 Units on a scale | Standard Deviation 2.724 |
| Ustekinumab 90mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24 | -2.17 Units on a scale | Standard Deviation 2.438 |
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change from baseline in hsCRP was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time frame: Baseline, Week 4, 8, 12, 16, 20 and 24
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants analyzed for this endpoint at specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 24 | -0.36 Milligrams per deciliter (mg/dL) | Standard Deviation 2.067 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 12 | -0.02 Milligrams per deciliter (mg/dL) | Standard Deviation 2.836 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 20 | 0.23 Milligrams per deciliter (mg/dL) | Standard Deviation 2.266 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 4 | 0.12 Milligrams per deciliter (mg/dL) | Standard Deviation 2.211 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 16 | -0.06 Milligrams per deciliter (mg/dL) | Standard Deviation 2.676 |
| Placebo | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 8 | -0.18 Milligrams per deciliter (mg/dL) | Standard Deviation 2.526 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 16 | -0.21 Milligrams per deciliter (mg/dL) | Standard Deviation 2.333 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 20 | -0.11 Milligrams per deciliter (mg/dL) | Standard Deviation 1.611 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 8 | -0.54 Milligrams per deciliter (mg/dL) | Standard Deviation 2.213 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 24 | -0.14 Milligrams per deciliter (mg/dL) | Standard Deviation 2.041 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 4 | -0.35 Milligrams per deciliter (mg/dL) | Standard Deviation 2.171 |
| Ustekinumab 45mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 12 | -0.36 Milligrams per deciliter (mg/dL) | Standard Deviation 2.495 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 24 | -0.26 Milligrams per deciliter (mg/dL) | Standard Deviation 1.85 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 4 | -0.12 Milligrams per deciliter (mg/dL) | Standard Deviation 1.604 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 8 | -0.24 Milligrams per deciliter (mg/dL) | Standard Deviation 2.555 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 12 | 0.05 Milligrams per deciliter (mg/dL) | Standard Deviation 2.842 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 16 | 0.12 Milligrams per deciliter (mg/dL) | Standard Deviation 2.72 |
| Ustekinumab 90mg | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 | Change at Week 20 | -0.40 Milligrams per deciliter (mg/dL) | Standard Deviation 2.198 |
Secondary
Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
ASAS 20 defined as improvement from baseline of \>= 20% from baseline and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week 24
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an ASAS 20 Response at Week 24 | 27.4 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved an ASAS 20 Response at Week 24 | 31.5 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved an ASAS 20 Response at Week 24 | 37.3 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\* duration of morning stiffness) + (0.579\*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).
Time frame: Week 24
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24 | 0 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24 | 2.7 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24 | 3.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
ASAS 20 defined as improvement from baseline of \>= 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week 4, 8, 12, 16 and 20
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 23.3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 24.7 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 19.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 20.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 28.8 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 30.1 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 26.0 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 34.2 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 21.9 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 35.6 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 41.8 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 35.8 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 31.3 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 32.8 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 29.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
ASAS 40 defined as improvement from baseline \>= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week 4, 8, 12, 16 and 20
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 9.6 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 6.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 6.8 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 11.0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 12.3 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 15.1 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 8.2 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 12.3 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 15.1 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 21.9 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 20 | 25.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 16 | 20.9 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 4 | 11.9 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 12 | 19.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20 | Week 8 | 16.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week 4, 8, 12, 16 and 20
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 20 | 8.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 4 | 5.5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 8 | 8.2 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 12 | 4.1 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 16 | 11.0 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 12 | 15.1 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 16 | 15.1 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 4 | 6.8 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 20 | 16.4 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 8 | 11.0 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 16 | 16.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 8 | 13.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 12 | 11.9 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 20 | 19.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 | Week 4 | 11.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Time frame: Week 24
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | 11.0 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | 15.1 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | 28.4 Percentage of participants |
Secondary
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\* duration of morning stiffness) + (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time frame: Week 4, 8, 12, 16 and 20
Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 20 | 1.4 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 12 | 1.4 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 4 | 0 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 8 | 2.7 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 16 | 1.4 Percentage of participants |
| Ustekinumab 45mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 20 | 1.4 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 20 | 1.5 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 16 | 3.0 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 4 | 0 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 12 | 3.0 Percentage of participants |
| Ustekinumab 90mg | Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 | Week 8 | 0 Percentage of participants |