Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 75 for:    "Collagen Disease" | "Triamcinolone"

RICE: Remission by Intra-articular Injection Plus CErtolizumab (RICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02293590
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Rüdiger B. Müller, Cantonal Hospital of St. Gallen

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Certolizumab Pegol Phase 2

Detailed Description:

Certolizumab pegol (CZP) is a tumor necrosis factor (TNF) antagonist which is marketed for the treatment of moderate to severe rheumatoid arthritis (RA) (Keystone, 2008) when given in combination with methotrexate (MTX). CZP is a PEGylated Fab' fragment of humanized anti-TNF antibody with a high affinity for TNF.

RA is a chronic inflammatory autoimmune disease with multiple treatment strategies and combination therapies available including analgesia, anti-inflammatory drugs and disease-modifying anti-rheumatic drugs. Previous trials have demonstrated positive results from the use of CZP but have compared its use to placebo in a fixed dose concomitant medication regime rather than using a more realistic dynamic treatment strategy normally employed in the clinical outpatient care of RA.

This trial is aimed at comparing the use of CZP in patients with moderate to severe RA when administered in conjunction with an intensive, adapted treatment strategy (Group A) versus a fixed-dosed program (Group B). CZP will be given in conjunction with MTX (a disease modifying anti-arthritic drug - or DMARD), steroidal therapy in the form of prednisolone and joint infiltrations of triamcinolone (another corticosteroid) and lidocaine (a pain therapy). Both treatment arms will include these concomitant medications but there will be an intensive adaptive approach adopted for the 'treat to target' population of Group A with a more fixed-dose approach set-out for Group B. Patients will be centrally randomized after screening to ensure a 50:50 ratio for both Groups in the study.

STUDY HYPOTHESIS

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study
Actual Study Start Date : November 2013
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intensive, adapted treatment strategy

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
Other Names:
  • Cimcia
  • Methoject
  • Lederlon
  • Leflunomid Gebro
  • Salazopyrin EN
  • Spiricort
  • Xyloneural

Active Comparator: fixed-dosed program

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
Other Names:
  • Cimcia
  • Methoject
  • Lederlon
  • Leflunomid Gebro
  • Salazopyrin EN
  • Spiricort
  • Xyloneural




Primary Outcome Measures :
  1. To assess the percentage of study participants achieving American College of Rheumatology 50% (ACR50) clinical response by the Week 24 assessments [ Time Frame: 24 weeks ]
    Efficacy rates as measured by the percentage of study participants achieving American College of Rheumatology 50% (ACR50) clinical response by the Week 24


Secondary Outcome Measures :
  1. To compare the efficacy rates of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment [ Time Frame: 8, 12, 18 and 24 weeks ]
    Efficacy rates as measured by ACR20/50/70 at weeks 8, 12, 18 and 24 weeks to determine the % of treatment responders in each study Group over the study period.

  2. 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 [ Time Frame: weeks 8, 12, 18 and 24 ]

    Efficacy rates as measured by patients achieving Low DAS is defined (LDAS) or a full clinical remission according to the EULAR at weeks 8, 12, 18 and 24 weeks. LDAS as a DAS-28 score of less than 3.2. The DAS-28 is defined by the number of tender and swollen joints calculated from 28 joints mainly from the upper limbs, the ESR and the patient's global assessment of disease activity.

    Remission will be defined as a DAS-28 score of less than 2.6 and/or according to the Boolean definition of remission (Felson 2011): swollen joint count, tender joint count, patients' global assessment of disease activity, CRP (mg/dl) all ≤1*


  3. To compare the relative time taken for patients to reach remission across the two treatment groups [ Time Frame: weeks 8, 12, 18 and 24 ]
    Efficacy rates as measured by the average number of weeks of treatment required for patients to reach remission of their RA. Clinical remission to be evaluated via the EULAR and DAS-remission criteria

  4. To compare the cumulative corticosteroid dose for patients across the two study treatment groups following 24 weeks of treatment [ Time Frame: 24 weeks ]
    Efficacy as calculated of the cumulative corticosteroid dose for patients completing the 24 week study period across the two treatment groupsCalculation of the cumulative corticosteroid dose for patients completing the 24 week study period across the two treatment groups

  5. To compare the safety and tolerability of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment [ Time Frame: 8, 12, 18 and 24 weeks ]
    Safety as calculated by the occurrence of treatment emergent adverse event (TEAE, adverse events occurring after baseline of the study) across the two treatment groups

  6. To conduct pharmacokinetic analysis to compare the CZP serum levels following 24 weeks of treatment across both of the treatment groups [ Time Frame: 24 weeks ]
    Efficacy analysis as analysed by a pharmacokinetic assessments are to be conducted at Visit 3/week 4 (day 28) and visit 7/Week 24 (Day 168 post initiation of CZP treatment)

  7. To compare the development of anti-CZP antibodies following 24 weeks of treatment across both of the treatment groups [ Time Frame: 24 weeks ]
    Efficacy analysis as analysed two single timepoint anti-CZP antibody assessments are to be conducted at Visit 2/Week 0 and Visit 7/Week 24 (Day 168 post initiation of CZP treatment)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293590


Locations
Layout table for location information
Switzerland
Kantonsspital St. Gallen
St. Gallen, Saint Gallen, Switzerland, 9007
Sponsors and Collaborators
Rüdiger B. Müller
UCB Pharma
Investigators
Layout table for investigator information
Study Chair: Rueediger B Mueller, MD Cantonal Hospital of St. Gallen

Layout table for additonal information
Responsible Party: Rüdiger B. Müller, Dr. med. Rüdiger Müller, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02293590     History of Changes
Other Study ID Numbers: EKSG13/104/2B
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Rüdiger B. Müller, Cantonal Hospital of St. Gallen:
Certolizumab pegol
DMARD
Joint injection
Glucocorticoids

Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Certolizumab Pegol
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents