ORBIT study

Outcomes in Rheumatoid arthritis By Intense Treatment

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR201208000399382

Enrollment

100

Registered

2012-07-23

Start date

2011-04-04

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Rheumatoid Arthritis

Interventions

CDAI

SDAI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) meet the 2011 revised American College of Rheumatology/EULAR classification criteria for RA 2) >18 years of age 3) naive to DMARD therapy at baseline 4) informed consent

Exclusion criteria

Exclusion criteria: Patients with contra-indication to methotrexate or corticosteroid therapy will be excluded (eg patients with Hepatitis B or C, HIV positive, pregnant or lactating or planning pregnancy within the next 12 months, uncontrolled diabetes mellitus)

Design outcomes

Primary

Measure	Time frame
To compare the clinical utility of the CDAI versus the SDAI in an intense outpatient management strategy in patients with early rheumatoid arthritis	—

Secondary

Measure	Time frame
To assess the outcomes of the two groups in terms of functional disability and health-related quality of life	—

Countries

South Africa

Contacts

Public ContactNthabiseng Monyai

study co-ordinator

nthabi.monyai@gmail.com+27 (0)11 933 9377

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026