The purpose of this research study is to evaluate the safety and effectiveness profile of the medicine named as Infimabâ?¢ in patients with moderate to severe plaque psoriasis which is a skin disease characterized by raised red patches covered with a silvery white buildup of dead skin cells or scale

A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of Infimabâ?¢ in patients with moderate to severe plaque psoriasis

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/09/021078

Enrollment

200

Registered

2019-09-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: Infimabâ?¢ (Infliximab): Infimabâ?¢ 5 mg/kg will be administered as intravenous infusion over a period of not less than 2 hours at Day 0, Week 2/ Day 14 and Week 6/ Day 42. Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 to 65 years (both inclusive). 2. Patients with confirmed diagnosis of plaque psoriasis since at least 6 months. 3. Patients with moderate to severe plaque psoriasis having PASI score >10. 4. Women of childbearing potential agreeing to use adequate contraception. 5. Able to understand and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with hypersensitivity to Infliximab or any of its components 2. Pregnant or lactating females 3. Presence of serious or active infection due to bacteria, fungi, viruses or other opportunistic pathogens 4. Patients with active or latent tuberculosis 5. Patients with history of any malignancy including lymphomas or presence of any premalignant lesions 6. Patients with heart failure (New York Heart Association class III or IV) 7. Patients with known hematological disorders, demyelinating disease or lupus-like syndrome 8. Patients with known clinically significant liver disease 9. Known cases of HIV, Hepatitis B or Hepatitis C infection 10. Patients with any condition that might make it difficult for patients to participate in the study or that might affect interpretation of results of the study, at the discretion of Investigator. 11. Participation in any clinical study of an investigational product within previous 3 months. 12. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events occurring during the studyTimepoint: Baseline to Week 14	—

Secondary

Measure	Time frame
Change in Physician Global Assessment (PGA) score from baseline to week 14Timepoint: From baseline to Week 14;Change in Psoriasis Area and Severity Index (PASI) score from baseline to week 14Timepoint: From baseline to Week 14	—

Countries

India

Contacts

Public ContactMs Chaitali Bornare

Reliance Life Sciences Pvt. Ltd. (RLS)

Supriya.Sonowal@relbio.com9427003728

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026