Back to resultsA Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Primary Purpose
Spondylitis, Ankylosing, Arthritis, Psoriatic
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Golimumab
Sponsored by
About this trial
This is an interventional treatment trial for Spondylitis, Ankylosing
Eligibility Criteria
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
Sites / Locations
- ChanRe Rheumatology & Immunology Center & Research
- Apollo Hospitals
- Chennai Meenakshi Multispeciality Hospital
- Nizams Institute of Medical Sciences NIMS
- Apollo Multispeciality Hospital Ltd
- All India Institute of Medical Sciences
- Sir Ganga Ram Hospital
- Indraprastha Apollo Hospital
- Sancheti Institute for Orthopedics & Rehabilitation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Golimumab
Arm Description
Participants will receive golimumab 50 milligram (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. Concomitant medications may be allowed on a case by case basis as per the physician's judgement.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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.
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).
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.
Full Information
NCT ID
NCT03733925
First Posted
November 5, 2018
Last Updated
December 27, 2022
Sponsor
Johnson & Johnson Private Limited
1. Study Identification
Unique Protocol Identification Number
NCT03733925
Brief Title
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Official Title
A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Private Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing, Arthritis, Psoriatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Golimumab
Arm Type
Experimental
Arm Description
Participants will receive golimumab 50 milligram (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. Concomitant medications may be allowed on a case by case basis as per the physician's judgement.
Intervention Type
Drug
Intervention Name(s)
Golimumab
Other Intervention Name(s)
SIMPONI
Intervention Description
Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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
Title
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14
Description
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
Title
Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14
Description
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
Title
Percentage of AS Participants With ASAS20 Criteria at Week 24
Description
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
Title
Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Private Limited Clinical Trial
Organizational Affiliation
Johnson & Johnson Private Limited
Official's Role
Study Director
Facility Information:
Facility Name
ChanRe Rheumatology & Immunology Center & Research
City
Bangalore
ZIP/Postal Code
560079
Country
India
Facility Name
Apollo Hospitals
City
Bhubaneswar
ZIP/Postal Code
751005
Country
India
Facility Name
Chennai Meenakshi Multispeciality Hospital
City
Chennai
ZIP/Postal Code
600004
Country
India
Facility Name
Nizams Institute of Medical Sciences NIMS
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Apollo Multispeciality Hospital Ltd
City
Kolkata
ZIP/Postal Code
700019
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
ZIP/Postal Code
1100776
Country
India
Facility Name
Sancheti Institute for Orthopedics & Rehabilitation
City
Pune
ZIP/Postal Code
411005
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
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