Trial Outcomes & Findings for Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis (NCT NCT01248793)

NCT ID: NCT01248793

Last Updated: 2013-03-20

Results Overview

Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 213 participants
• Primary outcome timeframe: Week 14
• Results posted on: 2013-03-20

Participant Flow

Participant milestones

Measure	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	Group II: Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Overall Study STARTED	105	108
Overall Study COMPLETED	101	102
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	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	Group II: Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Overall Study Lost to Follow-up	0	1
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Group I: Placebo n=105 Participants 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	Group II: Golimumab 50 mg n=108 Participants Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48	Total n=213 Participants Total of all reporting groups
Age Continuous	30.6 years STANDARD_DEVIATION 8.60 • n=5 Participants	30.5 years STANDARD_DEVIATION 10.27 • n=7 Participants	30.5 years STANDARD_DEVIATION 9.46 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	90 Participants n=7 Participants	177 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 14

Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment

Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

Outcome measures

Measure	Group I: Placebo n=105 Participants Placebo subcutaneous (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 20 if early escape	Group II: Golimumab 50 mg n=108 Participants Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14	26 Participants	53 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment

Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

Outcome measures

Measure	Group I: Placebo n=105 Participants Placebo subcutaneous (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 20 if early escape	Group II: Golimumab 50 mg n=108 Participants Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24	24 Participants	54 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Group I: Placebo n=105 Participants Placebo subcutaneous (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 20 if early escape	Group II: Golimumab 50 mg n=108 Participants Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14	0.113 Score on a scale Standard Deviation 2.0967	-1.262 Score on a scale Standard Deviation 2.5698

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Group I: Placebo n=105 Participants Placebo subcutaneous (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 20 if early escape	Group II: Golimumab 50 mg n=108 Participants Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14	-0.19 Score on a scale Standard Deviation 0.718	-0.42 Score on a scale Standard Deviation 0.906

Adverse Events

Placebo -> Golimumab 50 mg

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Golimumab 50 mg

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo -> Golimumab 50 mg n=103 participants at risk 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	Golimumab 50 mg n=108 participants at risk Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Eye disorders Uveitis	0.00% 0/103	0.93% 1/108
Gastrointestinal disorders Enteritis	0.97% 1/103	0.00% 0/108
Infections and infestations Tuberculous Pleurisy	0.97% 1/103	0.00% 0/108
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/103	0.93% 1/108
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Epithelial Cancer	0.00% 0/103	0.93% 1/108
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/103	0.93% 1/108

Other adverse events

Measure	Placebo -> Golimumab 50 mg n=103 participants at risk 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	Golimumab 50 mg n=108 participants at risk Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Infections and infestations Upper Respiratory Tract Infection	22.3% 23/103	22.2% 24/108
Investigations Alanine Aminotransferase Increased	6.8% 7/103	6.5% 7/108
Investigations Liver Function Test Abnormal	9.7% 10/103	4.6% 5/108
Investigations Transaminases Increased	5.8% 6/103	3.7% 4/108

Additional Information

Associate Director, Clinical Research

Janssen Research & Development

Phone: 610-500-3369

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60