A study to evaluate safety, tolerability and efficacy of a biosimilar Etanercept in India.

A phase IV, observational, practice based, open label, non-comparative, multicenter study to evaluate the safety, tolerability and efficacy of biosimilar of Etanercept in India.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/11/007466

Enrollment

200

Registered

2016-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: null- Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis(PsA) , Plaque Psoriasis, Juvenile Idiopathic Arthritis (JIA)

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients or their legally acceptable representative willing to give a written informed consent. 2. Males or Females having definite diagnosis of their rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis of 18 years and above or plaque psoriasis of 8 years and above or juvenile idiopathic arthritis of 2 years and above.

Exclusion criteria

Exclusion criteria: 1. Known allergy and hypersensitivity to Etanercept or any other component of medication. 2. Any known contradictions to Etanercept.

Design outcomes

Primary

Measure	Time frame
Safety •Incidence and nature of adverse events •Incidence of drug related adverse events. Timepoint: 24 weeks	—

Secondary

Measure	Time frame
The ACR 20 (20% improvement from baseline) The ACR 50 (50% improvement from baseline) Defined as 20 to 50 % improvement from baseline in a. Tender joint count b. Swollen joint count c. - Physician’s global assessment of disease activity d. - Patient’s global assessment of disease activity e. - Patient’s assessment of physical function using the disability domain of the HAQ (Indian Health Assessment Questionnaire) indexTimepoint: 24 weeks	—

Measure

Time frame

The ACR 20 (20% improvement from baseline) The ACR 50 (50% improvement from baseline) Defined as 20 to 50 % improvement from baseline in a. Tender joint count b. Swollen joint count c. - Physician’s global assessment of disease activity d. - Patient’s global assessment of disease activity e. - Patient’s assessment of physical function using the disability domain of the HAQ (Indian Health Assessment Questionnaire) indexTimepoint: 24 weeks

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Countries

India

Contacts

Public ContactRahul Namjoshi

Cipla Ltd.

abhay.phansalkar@cipla.com02224814909

Outcome results