Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis, unspecified
Conditions
Interventions
Long-term observation of treatment with abatacept.
After consenting, patients are clinically checked and routine blood samples will be taken at each study visit for ESR and CRP to compute disease act
Sponsors
Kings College London and Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/07/2021: 1. Male or female participants, aged =18 years. 2. All participants deemed eligible and randomised to the APIPPRA study. 3. All participants who completed at least one APIPPRA study visit. 4. All participants who are willing to give written informed consent and comply with the requirements of the ALTO study protocol. Previous inclusion criteria: 1. Male or female participants, aged =18 years 2. All participants deemed eligible and randomised to the APIPPRA study 3. All participants who completed at least one APIPPRA study visit 4. All participants who are willing to consent to the ALTO study
Exclusion criteria
Exclusion criteria: 1. Participants who are still participating in the APIPPRA study 2. Participants ineligible and randomised to the APIPPRA study in error 3. Participants deemed eligible and randomised to the APIPPRA study but who never received study drug 4. Those unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 20/07/2021: For those participants who met the APIPPRA primary endpoint during the APIPPRA study, this will be their primary endpoint in the ALTO study. For those study participants who did not meet the primary endpoint during the APIPPRA study, the primary endpoint in the ALTO study is the time from randomisation in the APIPPRA study to the development of clinical synovitis or RA defined by one of the following events, whichever is met first: 1. The development of clinically apparent synovitis in =3 joints, as determined by an assessor with experience in clinical assessment of RA 2. The development of RA according to the ACR/EULAR 2010 criteria, where joint involvement is defined as joint swelling 3. The prescription of first DMARD (e.g. methotrexate or equivalent) by a rheumatologist Previous primary outcome measures: 1. Inflammation of the joints assessed by physical examination 2. RA medication (time of commencing DMARD therapy) taken from medical records Timepoints: assessed at baseline and at every 6 monthly visit for max of 3 years (unless otherwise stated) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/07/2021: 1. The development of RA when imaging assessments are included, measured using tender and swollen joint counts and ultrasound, captured retrospectively then at baseline and every 6 months thereafter until 31/01/2023 2. Disease activity and progression over time, assessed using DAS28 (tender and swollen joint counts, patient global visual analogue score (VAS), CRP and ESR and Extended Joint Count 68/66, Simple Disease Activity Score (SDAI) and Clinical Disease Activity Score (CDAI), Pain VAS, Health Assessment Questionnaire (HAQ), Euro-Quality of Life Questionnaire (EQ-5D-3L), captured retrospectively then at baseline and every 6 months thereafter until 31/01/2023 3. The proportion of participants requiring conventional synthetic DMARD (csDMARD) therapy, and the time to commencing oral or parenteral corticosteroids, measured using clinical visits and electronic health records, captured retrospectively then at baseline and every 6 months thereafter until 31/01/2023 4. The proportion of participants requiring biologic DMARD therapy, and the time to commencing biologic DMARD therapy, measured using clinical visits and electronic health records captured retrospectively then at baseline and every 6 months thereafter until 31/01/2023 5. Radiographic changes in X-rays of the hands and feet from enrolment in APIPPRA to the end of ALTO, scored by van der Heijde Sharp Modified Scores at final visit by 31/01/2023 6. Safety, with emphasis on serious adverse events and events of special interest such as cardiovascular events, infection and cancer, assessed using clinical visits and electronic health records, captured retrospectively then at baseline and every 6 months thereafter until 31/01/2023 Previous secondary outcome measures: 1. Joint damage assessed by X-rays of hands and feet at the final visit 2. Quality of life assessed by Health Assessment Questionnaire (HAQ) 3. Quality of life assessed by Euro-Quality of Life Quest | — |
Countries
England, Netherlands, Scotland, United Kingdom
Outcome results
None listed