Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C0524T29 | Other Identifier | Centocor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental |
| |
| Golimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 24 |
| Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 |
Not provided
Inclusion Criteria:
- Have a diagnosis of definite akylosing spondylitis for at least 3 months
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24729398 | Derived | Bao C, Huang F, Khan MA, Fei K, Wu Z, Han C, Hsia EC. Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial. Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Group II: Golimumab 50 mg | Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment | Posted | Number | Participants | Week 14 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo -> Golimumab 50 mg | Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research | Janssen Research & Development | 610-500-3369 |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Golimumab |
| Drug |
Golimumab 50 mg SC injection every 4 weeks for 48 weeks |
|
| Golimumab (placebo group) | Drug | Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48 |
|
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. |
| Baseline and Week 14 |
| 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. | Baseline and Week 14 |
| Chengdu |
| China |
| Guangzhou | China |
| Hefei | China |
| Jinan | China |
| Shanghai | China |
| Xi'an | China |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Group II: Golimumab 50 mg |
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
|
|
| 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 | Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment | Posted | Number | Participants | Week 24 |
|
|
|
| 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. | Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 14 |
|
|
|
| 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. | Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 14 |
|
|
|
| 2 |
| 103 |
| 37 |
| 103 |
| EG001 | Golimumab 50 mg | Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 | 4 | 108 | 33 | 108 |
| Enteritis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tuberculous Pleurisy | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Ovarian Epithelial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
Not provided
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |