Trial to test the effectiveness of biologic drug Inj. Adalimumab for the management of primary osteoarthritis of knee joint and to compare its effectiveness with Intra-articular Triamcinolone.

An open label randomised controlled trial to compare the effectiveness of subcutaneous Injection Adalimumab with intra-articular triamcinolone in primary knee osteoarthritis. - ADAKOA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065428

Enrollment

Registered

2024-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Subcutaneous Inj. Adalimumab 40 mg: patients satisfying both inclusion and exclusion criteria and randomised to intervention arm will be given monthly subcutaneous Injection Adalimumab

Eligibility

Inclusion criteria

Inclusion criteria: Satisfying ACR criteria for classification and reporting of osteoarthritis of knee joint, 1986 Age 40-75 years Symptomatic for at-least 6 months Radiographic Kellgren-Lawrence grade II (definite osteophyte and unimpaired joint space) or grade III (moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour) Visual analog score for knee pain at-least 40 or more on the scale of 0-100

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Improvement in WOMAC pain subscale score (0-100) at 12 weeks.Timepoint: Improvement in WOMAC pain subscale score (0-100) at 12 weeks.	—

Secondary

Measure	Time frame
A) Percentage of patients achieving an Osteoarthritis Research Society International/Outcome Measure in Rheumatology Clinical trials (OARSI/OMERACT) response at week 12Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Biswadip Ghosh

IPGME&R Kolkata

drbiswadip@gmail.com9433272612

Outcome results

None listed

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