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

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ClinicalTrials.gov Identifier: NCT03733925
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Private Limited

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.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Arthritis, Psoriatic Drug: Golimumab Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 14, 2018
Estimated Primary Completion Date : January 25, 2021
Estimated Study Completion Date : January 25, 2021


Arm Intervention/treatment
Experimental: Golimumab
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.
Drug: Golimumab
Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.
Other Name: SIMPONI




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 24 ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.


Secondary Outcome Measures :
  1. Percentage of Ankylosing Spondylitis (AS) Participants with at least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14 [ Time Frame: Week 14 ]
    ASAS 20 defined as an improvement from baseline of greater than (>)20% and >1 unit on a 0 to 10 unit scale in at least 3 of following 4 ASAS domains and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0 to 10 units: Patient's global assessment (0 to 10 units numerical rating scale [NRS]: 0=not active spondylitis, 10=very active spondylitis); total back pain (0 to 10 units NRS: 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] on a 0 to 10 unit NRS: 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 on 0 to 10 unit NRS: 0=none, 10=very severe).

  2. Percentage of Psoriatic Arthritis (PsA) Participants meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14 [ Time Frame: Week 14 ]
    ACR20 is defined as greater than or equal to (>=)20% improvement in tender joint count and swollen 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 100 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; where 0=very well and 10cm=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.

  3. Percentage of AS Participants with ASAS20 Criteria at Week 24 [ Time Frame: Week 24 ]
    ASAS 20 defined as an improvement from baseline of greater than (>)20% and >1 unit on a 0 to 10 unit scale in at least 3 of following 4 ASAS domains and no worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0 to 10 units: Patient's global assessment (0 to 10 units numerical rating scale [NRS]: 0=not active spondylitis, 10=very active spondylitis); total back pain (0 to 10 units NRS: 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] on a 0 to 10 unit NRS: 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 on 0 to 10 unit NRS: 0=none, 10=very severe).

  4. Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24 [ Time Frame: Week 24 ]
    ACR20 is defined as >=20% improvement in tender joint count and swollen joint count and >=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 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 100 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; where 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733925


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
India
St. John's National Academy of Health Sciences - St. John's Medical College Hospital Not yet recruiting
Bangalore, India, 560034
ChanRe Rheumatology & Immunology Center & Research Not yet recruiting
Bangalore, India, 560079
Apollo Hospitals Not yet recruiting
Bhubaneswar, India, 751005
Meenakshi Mission Hospital and Research Center Not yet recruiting
Chennai, India, 625107
Apollo Gleneagles Hospital Not yet recruiting
Kolkata, India, 700054
All India Institute of Medical Sciences Not yet recruiting
New Delhi, India, 110029
Sir Ganga Ram Hospital Not yet recruiting
New Delhi, India, 110060
Fortis Hospital Not yet recruiting
Noida, India, 201301
Sponsors and Collaborators
Johnson & Johnson Private Limited
Investigators
Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited

Responsible Party: Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier: NCT03733925     History of Changes
Other Study ID Numbers: CR108559
CNTO148SPD4001 ( Other Identifier: Johnson & Johnson Private Limited )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Arthritis
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Spondylarthropathies
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Ankylosis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs