RICE: Remission by Intra-articular Injection Plus CErtolizumab

NCT02293590 | Completed Phase 2

• 1 other identifier: EKSG13/104/2B
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab pegol; DMARD; Joint injection; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• To assess the percentage of study participants achieving American College of Rheumatology 50% (ACR50) clinical response by the Week 24 assessments

  Efficacy rates as measured by the percentage of study participants achieving American College of Rheumatology 50% (ACR50) clinical response by the Week 24

  24 weeks

Secondary Outcomes (7)

• To compare the efficacy rates of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment

  8, 12, 18 and 24 weeks

• To compare the proportion of patients reaching either a low disease activity status (LDAS) or a full remission of their RA across both treatment groups at weeks 8, 12, 18 and 24

  weeks 8, 12, 18 and 24

• To compare the relative time taken for patients to reach remission across the two treatment groups

  weeks 8, 12, 18 and 24

• To compare the cumulative corticosteroid dose for patients across the two study treatment groups following 24 weeks of treatment

  24 weeks

• To compare the safety and tolerability of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment

  8, 12, 18 and 24 weeks

Study Arms (2)

intensive, adapted treatment strategy

EXPERIMENTAL

Experimental: intensive, adapted treatment strategy Certolizumab pegol (CZP, Cimzia (R)): 200mg every 2 weeks after loading d 400mg at Weeks 0, 2 and 4 DMARD: Patients without sufficient treatment response will be taken to the next step according to the therapeutic algorithm or next drug, for example: 15=\>25mg Metoject (R)/week =\> Leflunomide Gebro (R)20mg/d =\> Salazopyrine EN(R) 2000mg/d Glucocorticoids: At Week, 0 patients will be initiated on Spiricort (R) 20mg/d and tapered every 5 days Joint injections: Starting at Week 0 up to 5 joint injections may be conducted into synovitic joints at every visit of the study. The maximum cumulative Lederlon (R) dose is 100mg/visit. Joints are to be infiltrated with the following doses of triamcinolone and lidocaine

Drug: Certolizumab Pegol

fixed-dosed program

ACTIVE COMPARATOR

Intervention: Certolizumab pegol (Cimzia (R), CZP) CZP of 400mg at Weeks 0, 2 and 4, followed by 200mg injections from Week 6, every 2 weeks until Week 24. DMARD: Patients are to continue to receive their stable weekly dose of DMARD as noted at study entry for the duration of the study (24 weeks) Glucocorticoids: Prednisolone (Spiricort (R)) daily dose of ≤ 10 mg Joint injections: None

Drug: Certolizumab Pegol

Interventions

Certolizumab Pegol DRUG

Also known as: Cimcia, Methoject, Lederlon, Leflunomid Gebro, Salazopyrin EN, Spiricort, Xyloneural

fixed-dosed program; intensive, adapted treatment strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 years or older at the time of consent
• Able to give informed consent
• 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
• Has a been found to be intolerant to, or had an inadequate clinical response to at least 1 DMARD
• Is currently being treated with DMARDs for ≥ 12 weeks and has reached a stable dose for ≥ 4 weeks.
• 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.
• Available for the whole duration of the study.
• 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.
• 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).

You may not qualify if:

• 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)
• 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
• 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
• Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any untreated, chronic bacterial infection
• Having participated in another drug or an interventional study within 30 days preceding the present study screening
• Any previous treatment with CZP
• Any previous treatment with a biological DMARD

Sponsors & Collaborators

• Rüdiger B. Müller: lead
• UCB Pharma: collaborator

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol; Sulfadiazine; Lidocaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Acetanilides; Anilides

Study Officials

• Rueediger B Mueller, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Rüdiger Müller

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2013
• Primary Completion: December 22, 2017
• Study Completion: January 15, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

CH (1)