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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03733925
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Johnson & Johnson Private Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Johnson & Johnson Private Limited Clinical Trial
Principal Investigator Affiliation Johnson & Johnson Private Limited
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries India
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spondylitis, Ankylosing, Arthritis, Psoriatic
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Drug: - Golimumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bangalore, India

Status

Not yet recruiting

Address

St. John's National Academy of Health Sciences - St. John's Medical College Hospital

Bangalore, , 560034

Bangalore, India

Status

Recruiting

Address

ChanRe Rheumatology & Immunology Center & Research

Bangalore, , 560079

Apollo Hospitals, Bhubaneswar, India

Status

Recruiting

Address

Apollo Hospitals

Bhubaneswar, , 751005

Chennai, India

Status

Recruiting

Address

Chennai Meenakshi Multispeciality Hospital

Chennai, , 600004

Hyderabad, India

Status

Recruiting

Address

Nizams Institute of Medical Sciences NIMS

Hyderabad, , 500082

Apollo Gleneagles Hospital, Kolkata, India

Status

Recruiting

Address

Apollo Gleneagles Hospital

Kolkata, , 700054

All India Institute of Medical Sciences, New Delhi, India

Status

Not yet recruiting

Address

All India Institute of Medical Sciences

New Delhi, , 110029

Sir Ganga Ram Hospital, New Delhi, India

Status

Recruiting

Address

Sir Ganga Ram Hospital

New Delhi, , 110060

Indraprastha Apollo Hospital, New Delhi, India

Status

Recruiting

Address

Indraprastha Apollo Hospital

New Delhi, , 1100776

Pune, India

Status

Recruiting

Address

Sancheti Institute for Orthopedics & Rehabilitation

Pune, , 411005

Krishna Institute of Medical Sciences, Secunderabad, India

Status

Withdrawn

Address

Krishna Institute of Medical Sciences

Secunderabad, , 500003

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