Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201208000399382 Date of Approval: 23/07/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ORBIT study
Official scientific title Outcomes in Rheumatoid arthritis By Intense Treatment
Brief summary describing the background and objectives of the trial Rheumatoid arthritis (RA) is a chronic inflammatory arthritis, occurring worldwide and affecting 1% of the adult population. Aggressive therapy with disease modifying anti-rheumatic drugs (DMARDs) to suppress inflammation can prevent joint destruction and disability and maintain health-related quality of life. In this cross-sectional interventional study over 52 weeks, we explore pragmatic approaches to the management of early RA to best utilize limited resources.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ORBIT
Disease(s) or condition(s) being studied Rheumatoid Arthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/04/2011
Actual trial start date 03/05/2011
Anticipated date of last follow up 06/11/2017
Actual Last follow-up date 04/12/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Concealment by sealed envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CDAI monthly 5 years clinical disease activity index 50
Control Group SDAI monthly 5 years simplified disease activity index 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) 18 Year(s) 95 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/04/2011 Human Research Ethics Committee (Medical) UNIVERSITY OF THE WITWATERSRAND
Ethics Committee Address
Street address City Postal code Country
UNIVERSITY OF THE WITWATERSRAND JOHANNESBURG 2098 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the clinical utility of the CDAI versus the SDAI in an intense outpatient management strategy in patients with early rheumatoid arthritis 52 weeks; 5 years
Secondary Outcome To assess the outcomes of the two groups in terms of functional disability and health-related quality of life 52 weeks, 5 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital Rheumatology Outpatient department Old potch Rd, Soweto Gauteng 2014 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Connective Tissue Diseases Research Fund University of the Witwatersrand York road, Parktown Johannesburg 2098 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr B Hodkinson Chris Hani Baragwanath Academic Hospital, Soweto Johannesburg 2014 South Africa University
Secondary Sponsor Prof M Tikly Chris Hani Baragwanath Academic Hospital, Soweto Johannesburg 2014 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Mrs N Monyai Chris Hani Barahwanath Hospital Johannesburg 2015 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bridget Hodkinson drbridget@gmail.com +27 (0)82 3950503 Chris Hani Baragwanath Academic Hospital
City Postal code Country Position/Affiliation
Johannesburg 2014 South Africa consultant
Role Name Email Phone Street address
Public Enquiries Nthabiseng Monyai nthabi.monyai@gmail.com +27 (0)11 933 9377 Chris Hanagwanath academic Hospitali Bar
City Postal code Country Position/Affiliation
Johannesburg 2014 South Africa study co-ordinator
Role Name Email Phone Street address
Scientific Enquiries Mohammed Tikly tiklymohammed01@gmail.com +27 (0)11 933 9377 Chris Hani Baragwanath Academic Hospital
City Postal code Country Position/Affiliation
Johannesburg 2014 South Africa Head of Department
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information