Crohn's Disease, Psoriasis Chronic, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis, Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis
Interventions
DRUGInnovator infliximab
Sponsors
South-Eastern Norway Regional Health Authority
Diakonhjemmet Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis 2. Male or non-pregnant, non-nursing female 3. \>18 years of age at screening 4. Stable treatment with innovator infliximab (Remicade) during the last 6 months 5. Subject capable of understanding and signing an informed consent form 6. Provision of written informed consent
Exclusion criteria
1. Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases 2. Change of major co-medication during the last 2 months prior to randomization: RA, SpA and PsA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease. UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication which according to the investigator would interfere with the stability of the disease Psoriasis: Initiation of synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease 3. Inadequate birth control, pregnancy, and/or breastfeeding 4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible 5. Change in treatment with innovator infliximab (Remicade) during the last 6 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of disease worsening | 52 weeks | A disease worsening in RA and PsA is defined as an increase in DAS28 of ≥ 1.2 from randomization and a minimum DAS score of 3.2. A disease worsening in AS/SpA is defined as an increase in ASDAS of ≥1.1 from randomization and a minimum ASDAS of 2.1. A disease worsening in ulcerative colitis is defined as an increase in Partial Mayo score of ≥ 3 points from randomization and a minimum partial Mayo score of ≥ 5 points. A disease worsening in Crohn's disease is defined as an increase in HBI of ≥ 4 points from randomization and a minimum HBI score of 7 points. A disease worsening in psoriasis is defined as an increase in PASI of ≥ 3 points from randomization and a minimum PASI score of 5. If a patient does not fulfill the formal definition, but experiences a clinically significant worsening according to both the investigator and patient and which leads to a major change in treatment this should be considered as a disease worsening but recorded separately in the CRF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission status according to DAS28 | 52 weeks | For RA and PsA patients |
| Remission status according to ACR/EULAR | 52 weeks | For RA and PsA patients |
| Disease activity according to ACR/EULAR | 52 weeks | For RA and PsA patients |
| Remission status according to ASDAS | 52 weeks | For SpA patients |
| Disease activity according to ASDAS | 52 weeks | For SpA patients |
| Remission status according to Partial Mayo Score | 52 weeks | For UC patients |
| Disease activity according to Partial Mayo Score | 52 weeks | For UC patients |
| Disease activity according to Harvey-Bradshaw index | 52 weeks | For CD patients |
| Remission status according to PASI | 52 weeks | For psoriatic patients |
| Disease activity according to PASI | 52 weeks | For psoriatic patients |
| Remission status according to Harvey-Bradshaw index | 52 weeks | For CD patients |
| Time to disease worsening | 52 weeks | — |
| Occurrence of study drug discontinuation | 52 weeks | — |
| Time to study drug discontinuation | 52 weeks | — |
| Patient's global assessment of disease activity | 52 weeks | — |
| Physicians's global assessment of disease activity | 52 weeks | — |
| Inflammation laboratory parameters | 52 weeks | ESR and CRP for all patients, Calprotectin for UC and CD patients |
| Disease activity according to DAS28 | 52 weeks | For RA and PsA patients |
| Remission status according to CDAI | 52 weeks | For RA and PsA patients |
| Disease activity according to CDAI | 52 weeks | For RA and PsA patients |
| Remission status according to SDAI | 52 weeks | For RA and PsA patients |
| Disease activity according to SDAI | 52 weeks | For RA and PsA patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 52 weeks | Only UC and CD patients |
| Dermatology Life Quality Index (DLQI) | 52 weeks | Only Ps patients |
| EQ-5D | 52 weeks | — |
| RAID | 52 weeks | Only RA patients |
| PsAID | 52 weeks | Only PsA patients |
| WPAI:GH | 52 weeks | Work Productivity and Activity Impairment Questionnaire: General health |
| Safety and tolerability: AEs, laboratory parameters | through study completion, an average of 52 weeks | — |
| Modified Health Assessment Questionnaire (MHAQ) | 52 weeks | Only RA, SpA and PsA patients |
| RAND SF-36 | 52 weeks | — |
Countries
Norway
Outcome results
None listed