Arthritis, Psoriatic, Spondylitis, Ankylosing
Conditions
Brief summary
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
Detailed description
This post-marketing study will evaluate safety and efficacy profile of golimumab (a fully human anti-Tumour Necrosis Factor alpha \[TNF-alpha\] monoclonal antibodies \[mAb\], administered subcutaneously) in a real-world in Indian participants with active spondyloarthropathy of ankylosing spondylitis (AS) or psoriatic arthritis (PsA). AS is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses, and peripheral joints. PsA is a chronic, inflammatory, usually rheumatoid factor negative arthritis that is associated with psoriasis. Golimumab binds with high affinity to human TNF-alpha and inhibits TNF-alpha bioactivity, TNF-alpha-mediated cell cytotoxicity and TNF-alpha mediated endothelial cell activation. Golimumab also induces activation of complement-mediated cell lysis and reduces the development of arthritis. Study evaluation includes efficacy (efficacy parameters for AS and PsA) and safety. Participant's safety will be monitored throughout the study. The total duration of study will be approximately 24 weeks.
Interventions
DRUGGolimumab
Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.
Sponsors
Johnson & Johnson Private Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For participants with Ankylosing Spondylitis (AS): * Have a diagnosis of definite AS (according to the Modified New York Criteria) * Either has an inadequate response (defined as Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] greater than or equal to \[\>=\]4) to current or past therapies (including biologics naïve participants). Participants who were receiving non-steroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs) had to have received continuous therapy for 3 months at the highest recommended doses or had to have been unable to receive a full 3-month course of full-dose NSAID or DMARD therapy because of intolerance, toxicity, or contraindications. Maximum recommended dosages for DMARDs if used, would be: methotrexate 25 milligram per week (mg/week), oral corticosteroids (less than or equal to \[\<=\]10 milligram per day \[mg/day\] of prednisone or equivalent) or sulfasalazine 3 gram per day (g/day) For participants with Psoriatic Arthritis (PsA): * Have PsA that was diagnosed at least 6 months prior to the first administration of study drug (according to the ClASsification criteria for Psoriatic ARthritis \[CASPAR\]) * Have at least 1 of the PsA subsets: Distal Interphalangeal (DIP) joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis * Are negative for rheumatoid factors according to the reference range of the local laboratory conducting the test
Exclusion criteria
* Are pregnant, nursing, or planning a pregnancy or fathering a child during the study or within 6 months after receiving the last administration of study drug * Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab * Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to screening * Have a chest radiograph within 3 months prior to the first administration of study drug that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB) * Have had a nontuberculous mycobacterial infection or opportunistic infection (for example, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 32 | 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. |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | Up to Week 32 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 | Week 14 | 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). |
| Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 | Week 14 | 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. |
| Percentage of AS Participants With ASAS20 Criteria at Week 24 | Week 24 | 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). |
| Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 | Week 24 | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Golimumab (Simponi) Participants with active spondyloarthropathy of AS or PsA received golimumab 50 milligrams (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-Compliance with Study Drug | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Golimumab (Simponi) |
|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 12.02 |
| Race/Ethnicity, Customized Indian | 100 Participants |
| Region of Enrollment India | 100 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 28 / 100 |
| serious Total, serious adverse events | 4 / 100 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: Up to Week 32
Population: Safety analysis set (SAS) included all participants who were enrolled and received at least one dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Golimumab (Simponi) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Psoriatic Arthritis (PsA) | 18 Participants |
| Golimumab (Simponi) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Ankylosing Spondylitis (AS) | 10 Participants |
Primary
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
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.
Time frame: Up to Week 32
Population: SAS included all participants who were enrolled and received at least one dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Golimumab (Simponi) | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | AS | 2 Participants |
| Golimumab (Simponi) | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | PsA | 2 Participants |
Secondary
Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14
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).
Time frame: Week 14
Population: The intent to treat (ITT) analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 14 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab (Simponi) | Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 | 74.5 percentage of participants |
Secondary
Percentage of AS Participants With ASAS20 Criteria at Week 24
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).
Time frame: Week 24
Population: The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 24 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab (Simponi) | Percentage of AS Participants With ASAS20 Criteria at Week 24 | 66.0 percentage of participants |
Secondary
Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24
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.
Time frame: Week 24
Population: The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 24 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab (Simponi) | Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 | 93.2 percentage of participants |
Secondary
Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14
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.
Time frame: Week 14
Population: The ITT analysis set included all participants who were enrolled and received at least one dose of the study drug and had completed Week 14 visit. Here, N (number of participants analyzed) is defined as the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab (Simponi) | Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 | 84.6 percentage of participants |