To find out which is better mode of steroid therapy for early Rheumatoid arthritis.

Efficacy of low dose short term oral vs intramuscular (IM)single dose prednisolone as bridge therapy in newly diagnosed rheumatoid arthritis patients on standard of care- a pragmatic clinical trial - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059794

Enrollment

208

Registered

2023-11-14

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: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: NIL: NIL Intervention2: prednisolone: taken by oral , 80 mg dose , duration is 1 month Control Intervention1: Oral prednisolone: Injection prednisolone Control Intervention2: oral pred

Eligibility

Inclusion criteria

Inclusion criteria: RA patients (newly diagnosed) DAS28 ESR greater 3.2

Exclusion criteria

Exclusion criteria: younger than 18 years older than 75 years

Design outcomes

Primary

Measure	Time frame
To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or parenteral (IM) prednisone in addition to SoC therapy. [EULAR Good response is defined as DAS28 =3.2 & a decline by 1.2. Moderate response is defined as a DAS28 =3.2 plus a decrease 0.6 and =1.2, OR a DAS28 =5.1 3.2 plus decline of 0.6, OR a DAS28 5.1 and a decrease 1.2] Timepoint: 30days	—

Measure

Time frame

To estimate the difference in proportion of patients reporting EULAR good or moderate response at 1 month in those administered oral or parenteral (IM) prednisone in addition to SoC therapy. [EULAR Good response is defined as DAS28 =3.2 & a decline by 1.2. Moderate response is defined as a DAS28 =3.2 plus a decrease 0.6 and =1.2, OR a DAS28 =5.1 3.2 plus decline of 0.6, OR a DAS28 5.1 and a decrease 1.2] Timepoint: 30days

—

Secondary

Measure	Time frame
Difference in proportion of patients reporting EULAR good or moderate response at 2 months Difference in trajectory of response in HAQ & RAPID 3 at day 7, 1month & 2 months Difference in DAS 28 ESR improvement at 1 & 2 months Difference in proportion of patients achieving delta HAQ 1.2 HAQ at baseline, 7 days (telephonic), 1 month & 2 months Cost effectiveness of the 2 arms of treatment Differences in adverse effects Timepoint: 8 months	—

Measure

Time frame

Difference in proportion of patients reporting EULAR good or moderate response at 2 months Difference in trajectory of response in HAQ & RAPID 3 at day 7, 1month & 2 months Difference in DAS 28 ESR improvement at 1 & 2 months Difference in proportion of patients achieving delta HAQ 1.2 HAQ at baseline, 7 days (telephonic), 1 month & 2 months Cost effectiveness of the 2 arms of treatment Differences in adverse effects Timepoint: 8 months

—

Countries

India

Contacts

Public ContactVidya

St Johns Medical College and Hospital

vidu.micro@gmail.com9611578090

Outcome results

None listed

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