Improving outcomes for patients with rheumatoid arthritis with intermediate disease - is intensive management more effective than standard care?

Conditions

Rheumatoid arthritis Musculoskeletal Diseases

Fowzia Ibrahim, David L. Scott, Ian C. Scott

BMC Rheumatology2025-05-21

10.1186/s41927-025-00493-z

Intensive therapy for moderate established rheumatoid arthritis: the TITRATE research programme

David L. Scott, Fowzia Ibrahim, Harry Hill, Brian D. M. Tom, Louise Prothero et al. (17 authors)

Programme Grants for Applied Research2021-08-019 citations

10.3310/pgfar09080

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial.

Martin NH, Ibrahim F, Tom B, Galloway J, Wailoo A, Tosh J, Lempp H, Prothero L, Georgopoulou S, Sturt J, Scott DL, TITRATE Programme Investigators.

2017-12-0811 citations

10.1186/s13063-017-2330-8

Interventions

The study will compare standard care with intensive management over a period of 12 months. Intensive management will involve monthly sessions with a trained specialist nurse or health

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/06/2015: 1. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria) 2. Have received at least one DMARD for at least six months, and currently receiving at least one DMARD 3. Have intermediate disease activity, defined by: 3.1. DAS28-ESR 3.2-5.1. 3.2. At least three active joints (defined as swollen and/or tender) on 66/68 joint count, to include at least one swollen joint 4. Willing and able to follow an intensive management programme 5. Able and willing to give informed consent Previous inclusion criteria: 1. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria); duration six months to 10 years 2. Have received at least one DMARD for at least six months, and currently receiving at least one DMARD 3. Have intermediate disease activity, defined by: 3.1. DAS28-ESR 3.2-5.1. 3.2. At least three swollen joints and three tender joints on 66/68 joint count 4. Willing and able to follow an intensive management programme 5. Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Major co-morbidities making intensive treatment inadvisable (e.g. heart failure) 2. Previously failed multiple DMARDs (more than or equal to 5 treatments) or having received biologics 3. Irreversible disability from extensive joint damage (for example, replacement of three or more major joints) 4. Women who are pregnant, breastfeeding or planning to conceive 5. Currently in early RA pathway 6. Current or recent (within the previous 12 weeks) participation in another interventional trial

Design outcomes

Primary

Measure	Time frame
Disease remission at 12 months (final assessment) measured by the Disease Activity Score-28 (DAS28) criterion (DAS28-ESR<2.6)	—

Secondary

Measure	Time frame
1. Alternative assessments of remission: Remission measured by the DAS28-CRP and the Simplified Disease Activity Index (SDAI) (remission defined as SDAI=3.3) at 12 months; remission assessed by all measures at six months. 2. Assessment of Individual Components of Remission: Tender joint counts (68 joints), swollen joint counts (66 joints), patient global assessments on 100mm visual analogue scales (VAS), physician global assessments on 100mm VAS, C-Reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR) at baseline, 6 months and 12 months. 3. Disability: Health Assessment Questionnaire (HAQ) at baseline, 6 months and 12 months. 4. Joint Imaging (Predictor of future disability): Plain X-rays of the hands and feet read by a modified Larsen's score at baseline and 12 months. 5. Quality Of Life: EuroQOL 5 Dimensional score (EQ5D-5L) and patient-rated fatigue scale on 100mm VAS at baseline, six and 12 months. 6. Patient Acceptability: Modified version of the Measuring Actual Patient-led Expectations in Rheumatoid Arthritis (MAPLe-RA) questionnaire at baseline and 12 months, Medication Adherence Rating Scale (MARS) and adverse events at baseline, six and 12 months. 7. Economic Assessments: Modified Client Service Receipt Inventory (CSRI) at baseline, six and 12 months.	—

Measure

Time frame

1. Alternative assessments of remission: Remission measured by the DAS28-CRP and the Simplified Disease Activity Index (SDAI) (remission defined as SDAI=3.3) at 12 months; remission assessed by all measures at six months. 2. Assessment of Individual Components of Remission: Tender joint counts (68 joints), swollen joint counts (66 joints), patient global assessments on 100mm visual analogue scales (VAS), physician global assessments on 100mm VAS, C-Reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR) at baseline, 6 months and 12 months. 3. Disability: Health Assessment Questionnaire (HAQ) at baseline, 6 months and 12 months. 4. Joint Imaging (Predictor of future disability): Plain X-rays of the hands and feet read by a modified Larsen's score at baseline and 12 months. 5. Quality Of Life: EuroQOL 5 Dimensional score (EQ5D-5L) and patient-rated fatigue scale on 100mm VAS at baseline, six and 12 months. 6. Patient Acceptability: Modified version of the Measuring Actual Patient-led Expectations in Rheumatoid Arthritis (MAPLe-RA) questionnaire at baseline and 12 months, Medication Adherence Rating Scale (MARS) and adverse events at baseline, six and 12 months. 7. Economic Assessments: Modified Client Service Receipt Inventory (CSRI) at baseline, six and 12 months.

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Countries

England, United Kingdom

Outcome results

None listed