RICE: Remission by Intra-articular Injection Plus CErtolizumab

• Status: Completed
• Trial end date: 2018-01-15
• Target enrollment: 0
• Participant gender: All

Summary

Tight control of an adaptive concomitant treatment strategy after initiation of CZP will lead to an improved outcome of RA patients with an active disease despite DMARD treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rüdiger B. Müller
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol; Glucocorticoids; Sulfasalazine

Criteria

Inclusion Criteria:

1. Male or female subjects aged 18 years or older at the time of consent

2. Able to give informed consent

3. Patients diagnosed as having established and active rheumatoid arthritis classified according to the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria (Aletaha D et al 2010) for a period of ≥ 3 months counting from the first DMARD treatment initiated. Active rheumatoid arthritis is characterised as all of the following:

• ≥6 tender joint out of the 68 joint count

• ≥6 swollen joints out of the 66 joint count

• ESR ≥ 20mm/h or CRP ≥7mg/l

4. Has a been found to be intolerant to, or had an inadequate clinical response to at least 1 DMARD

5. Is currently being treated with DMARDs for ≥ 12 weeks and has reached a stable dose for ≥ 4 weeks.

6. Is currently receiving a corticosteroid (e.g. prednisolone or equivalent) and has reached a stable dose of ≤ 10mg/d for ≥ 4 weeks (patients without current corticosteroid treatment for ≥ 4 weeks may also be included.

7. Available for the whole duration of the study.

8. Female subjects of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for the duration of the study (starting from randomisation and ending up to Week 24 at Day 168/Safety follow-up visit). Must have a negative pregnancy test upon entry into the study. Otherwise, female subjects must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.

9. Male subjects must be surgically sterile or willing to use a double barrier contraception method upon enrolment, for the duration of the study (starting from randomisation and ending up to Week 24 at Day 168/Safety follow-up visit).

Exclusion Criteria:

1. Pregnant or breastfeeding women or such with a child-bearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period (up to Week 24 at Day 168/Safety follow-up visit)

2. Subjects with a history of cancer in the last 5 years, or with a current screening suspicious for cancer, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ

3. Subjects with evidence of untreated, active or latent bacterial (e.g. tuberculosis) or viral infections (e.g. Human Immunodeficiency Virus (HIV), Hepatitis B or C) at the time of potential enrolment

4. Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any untreated, chronic bacterial infection

5. Having participated in another drug or an interventional study within 30 days preceding the present study screening

6. Any previous treatment with CZP

7. Any previous treatment with a biological DMARD