Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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).
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Johnson & Johnson Private Limited|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Spondylitis, Ankylosing, Arthritis, Psoriatic|
|Study Website:||View Trial Website|
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.
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.
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.