Trial Outcomes & Findings for A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis (NCT NCT03733925)

A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE.

ASAS 20 response criteria was defined as an improvement from baseline of greater than (\>)20% and \>1 unit in at least 3 of following 4 ASAS domains on scale of 0-10 units and no worsening from baseline of \>20% and \>1 unit in the remaining ASAS domain on a scale of 0-10 units. The 4 ASAS domains were as follows (0-10 units numerical rating scale \[NRS\]): Patient's global assessment (PGA) of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; bath ankylosing spondylitis functional index (BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions \[8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and bath ankylosing spondylitis disease activity index (BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).

ACR20 was is defined as greater than or equal to (\>=) 20% improvement in swollen and tender joint count and \>=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter \[cm\], 0 cm=no pain and 10 cm=worst possible pain), PGA of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, \[0 cm=no pain to 10 cm=worst possible pain\]), physician's global assessment of disease activity using VAS (scale ranges from 0 cm to 10 cm; \[0 cm=very well and 10 cm=very poor\]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level.

ASAS 20 response criteria was defined as an improvement from baseline of greater than (\>) 20% and \>1 unit in at least 3 of following 4 ASAS domains on scale of 0 to 10 units and no worsening from baseline of \>20% and \>1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains were as follows (0 to 10 units NRS): PGA of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions \[8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life): 0=easy, 10=impossible; and BASDAI, self-assessment survey of 6 questions for participant's disability due to AS): 0=none, 10=very severe).

ACR20 was is defined as \>=20% improvement in swollen and tender joint count and \>=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter \[cm\], 0 cm=no pain and 10 cm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, \[0 cm=no pain to 10 cm=worst possible pain\]), PGA of disease activity using VAS (scale ranges from 0 cm to 10 cm; \[0=very well and 10 cm=very poor\]), participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR or CRP level.