Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Sponylitis, injection, golimumab, simponi
Brief summary
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
Detailed description
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.
Interventions
DRUGPlacebo
Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20
DRUGGolimumab
Golimumab 50 mg SC injection every 4 weeks for 48 weeks
DRUGGolimumab (placebo group)
Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48
Sponsors
Centocor, Inc.
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
\- Have a diagnosis of definite akylosing spondylitis for at least 3 months * Have symptoms of active disease at screening and at baseline * no active infections
Exclusion criteria
* Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy * Have complete ankylosis of the spine * Have a history of latent or active granulomatous infection * Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 | Week 14 | Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 | Week 24 | Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation |
| Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 | Baseline and Week 14 | BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale \[Score\]; 0 cm \[easy\] to 10 cm \[impossible\]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement. |
| Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 | Baseline and Week 14 | BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I: Placebo Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape | 105 |
| Group II: Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 | 108 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Group I: Placebo | Group II: Golimumab 50 mg | Total |
|---|---|---|---|
| Age Continuous | 30.6 years STANDARD_DEVIATION 8.6 | 30.5 years STANDARD_DEVIATION 10.27 | 30.5 years STANDARD_DEVIATION 9.46 |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 87 Participants | 90 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 103 | 33 / 108 |
| serious Total, serious adverse events | 2 / 103 | 4 / 108 |
Outcome results
Primary
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14
Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
Time frame: Week 14
Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I: Placebo | Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 | 26 Participants |
| Group II: Golimumab 50 mg | Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 | 53 Participants |
Secondary
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
Time frame: Week 24
Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I: Placebo | Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 | 24 Participants |
| Group II: Golimumab 50 mg | Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 | 54 Participants |
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale \[Score\]; 0 cm \[easy\] to 10 cm \[impossible\]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 14
Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I: Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 | 0.113 Score on a scale | Standard Deviation 2.0967 |
| Group II: Golimumab 50 mg | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 | -1.262 Score on a scale | Standard Deviation 2.5698 |
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14
BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.
Time frame: Baseline and Week 14
Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I: Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 | -0.19 Score on a scale | Standard Deviation 0.718 |
| Group II: Golimumab 50 mg | Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 | -0.42 Score on a scale | Standard Deviation 0.906 |