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

NCT03733925 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CR108559CNTO148SPD4001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Week 32

• 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.

  Up to Week 32

Secondary Outcomes (4)

• 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

• Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14

  Week 14

• Percentage of AS Participants With ASAS20 Criteria at Week 24

  Week 24

• Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24

  Week 24

Study Arms (1)

Golimumab

EXPERIMENTAL

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

Interventions

Golimumab DRUG

Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.

Also known as: SIMPONI

Golimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (9)

ChanRe Rheumatology And Immunology Center And Research

Bangalore, 560079, India

Location

Apollo Hospitals

Bhubaneswar, 751005, India

Location

Chennai Meenakshi Multispeciality Hospital

Chennai, 600004, India

Location

Nizams Institute of Medical Sciences NIMS

Hyderabad, 500082, India

Location

Apollo Multispeciality Hospital Ltd

Kolkata, 700019, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Indraprastha Apollo Hospital

New Delhi, 1100776, India

Location

Sancheti Institute for Orthopedics & Rehabilitation

Pune, 411005, India

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Advisor Immunology
• Organization: Johnson & Johnson Private Limited

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Johnson & Johnson Private Limited Clinical Trial

  Johnson & Johnson Private Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: January 7, 2019
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: February 4, 2025
• Results First Posted: January 20, 2023

Record last verified: 2025-01

Locations

IN (9)