Investigating the difference between infliximab treatment injected into a vein and injected under the skin in patients with inflammatory bowel disease and inflammatory arthritis already established on infliximab injected into a vein

SWitching InflixiMab to SUbcut from Intravenous Therapy (SWIMSUIT)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13323475

Enrollment

200

Registered

2021-02-10

Start date

2021-02-25

Completion date

Unknown

Last updated

2022-02-01

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

Conditions

Ulcerative colitis, crohn's disease, rheumatoid arthritis, psoriatic arthritis, or ankylosis spondylitis Not Applicable Ulcerative colitis, Crohn's disease, rheumatoid arthritis, psoriatic arthritis, or ankylosis spondylitis

Interventions

This study will aim to recruit participants with inflammatory bowel disease or inflammatory arthritis who are being treated with intravenous (IV) infliximab as part of their routine clinical care. Par

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and/or ankylosis spondylitis 2. Established on IV infliximab (>4 doses) prior to study enrolment 3. Anticipated to remain on infliximab for the duration of the study 4. Last dose of IV infliximab received <8 weeks ago 5. Able to comply with study requirements 6. Able to provide informed consent 7. Aged =18 years

Exclusion criteria

Exclusion criteria: 1. Allergic to any of the known excipients of infliximab 2. Scheduled for a surgical procedure or planned hospitalisation within 6 months of enrolment 3. Not anticipated to remain on infliximab for >6 months after enrolment 4. Pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Clinical status at 24 weeks measured using the following at baseline, 12, and 24 weeks: 1. For Crohn's disease patients: Modified Harvey-Bradshaw Index (mHBI) and IBD Control (IBD-CTRL) Patient Reported Outcome Measure (PROM). An increase in mHBI score of =3 and/or a decline in IBD-CTRL score of =4 points at any time during the respective study period will be classified as failure to maintain baseline clinical status. 2. For ulcerative colitis patients: Simple Clinical Colitis Activity Index (SCCAI) (UC) and IBD Control (IBD-CTRL) Patient Reported Outcome Measure (PROM). An increase in SCCAI =3 score and/or a decline in IBD-CTRL score of =4 points at any time during the respective study period will be classified as failure to maintain baseline clinical status. 3. For rheumatoid arthritis and psoriatic arthritis patient’s: Clinical Disease Activity Index/Simplified Disease Activity Index (CDAI/SDAI) and Disease Activity Score from 28 joints (DAS28) where an increase of >0.6 or a score of >5.1 deemed to be a failure 4. For ankylosis spondylitis patients: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) where a >50% worsening of BASDAI score will be deemed a failure	—

Measure

Time frame

Clinical status at 24 weeks measured using the following at baseline, 12, and 24 weeks: 1. For Crohn's disease patients: Modified Harvey-Bradshaw Index (mHBI) and IBD Control (IBD-CTRL) Patient Reported Outcome Measure (PROM). An increase in mHBI score of =3 and/or a decline in IBD-CTRL score of =4 points at any time during the respective study period will be classified as failure to maintain baseline clinical status. 2. For ulcerative colitis patients: Simple Clinical Colitis Activity Index (SCCAI) (UC) and IBD Control (IBD-CTRL) Patient Reported Outcome Measure (PROM). An increase in SCCAI =3 score and/or a decline in IBD-CTRL score of =4 points at any time during the respective study period will be classified as failure to maintain baseline clinical status. 3. For rheumatoid arthritis and psoriatic arthritis patient’s: Clinical Disease Activity Index/Simplified Disease Activity Index (CDAI/SDAI) and Disease Activity Score from 28 joints (DAS28) where an increase of >0.6 or a score of >5.1 deemed to be a failure 4. For ankylosis spondylitis patients: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) where a >50% worsening of BASDAI score will be deemed a failure

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Secondary

Measure	Time frame
1.Safety and tolerability measured using the incidence of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI) causally related to Infliximab between baseline and 24 weeks 2. Pharmacokinetics measured using blood samples to determine drug trough levels at baseline, 12, and 24 weeks 3. Immunogenicity measured using the presence of anti-drug antibodies in blood samples baseline, 12, and 24 weeks 4. Quality of life measured using the following at baseline, 12, and 24 weeks: 4.1. For Crohn's disease and ulcerative colitis patients: Short Form 36 Health Survey Questionnaire (SF-36) and IBD Control (IBD-CTRL) Patient-Reported Outcome Measure (PROM) 4.2. For rheumatoid arthritis, psoriatic arthritis and ankylosis spondylitis patients: SF-36, pain visual analogue score (VAS), and Health Assessment Questionnaire Disability Index (HAQ-DI), and one of the following, as appropriate: Bath Ankylosing Spondylitis Functional Index (BASFI), Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, or Rheumatoid Arthritis Impact of Disease (RAID) questionnaire 5. Levels of laboratory inflammatory markers measured using the following at baseline, 12, and 24 weeks: 5.1. For all participants: Full Blood Count (FBC), C-reactive protein (CRP), and serum albumin from blood samples 5.2. For Crohn's disease and ulcerative colitis patients: faecal calprotectin from stool samples 5.3. For rheumatoid arthritis, psoriatic arthritis and ankylosis spondylitis patients: Erythrocyte sedimentation rate (ESR) from blood samples 6. Patient experience measured using semi-structured interviews analysed using thematic analysis, IBD control Patient-Reported Outcome Measure (PROM), patient Treatment Satisfaction Questionnaire for Medicine (TSQM), Disease-specific PROM for rheumatology patients (HAQ-DI an	—

Measure

Time frame

1.Safety and tolerability measured using the incidence of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI) causally related to Infliximab between baseline and 24 weeks 2. Pharmacokinetics measured using blood samples to determine drug trough levels at baseline, 12, and 24 weeks 3. Immunogenicity measured using the presence of anti-drug antibodies in blood samples baseline, 12, and 24 weeks 4. Quality of life measured using the following at baseline, 12, and 24 weeks: 4.1. For Crohn's disease and ulcerative colitis patients: Short Form 36 Health Survey Questionnaire (SF-36) and IBD Control (IBD-CTRL) Patient-Reported Outcome Measure (PROM) 4.2. For rheumatoid arthritis, psoriatic arthritis and ankylosis spondylitis patients: SF-36, pain visual analogue score (VAS), and Health Assessment Questionnaire Disability Index (HAQ-DI), and one of the following, as appropriate: Bath Ankylosing Spondylitis Functional Index (BASFI), Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, or Rheumatoid Arthritis Impact of Disease (RAID) questionnaire 5. Levels of laboratory inflammatory markers measured using the following at baseline, 12, and 24 weeks: 5.1. For all participants: Full Blood Count (FBC), C-reactive protein (CRP), and serum albumin from blood samples 5.2. For Crohn's disease and ulcerative colitis patients: faecal calprotectin from stool samples 5.3. For rheumatoid arthritis, psoriatic arthritis and ankylosis spondylitis patients: Erythrocyte sedimentation rate (ESR) from blood samples 6. Patient experience measured using semi-structured interviews analysed using thematic analysis, IBD control Patient-Reported Outcome Measure (PROM), patient Treatment Satisfaction Questionnaire for Medicine (TSQM), Disease-specific PROM for rheumatology patients (HAQ-DI an

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Countries

England, United Kingdom

Outcome results

None listed

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