A Phase 2 interventional study of Certolizumab Pegol in Rheumatoid Arthritis, sponsored by Rüdiger B. Müller. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Rüdiger B. Müller · Phase 2, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 43 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Rüdiger B. Müller is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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
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
Also known as: Cimcia, Methoject, Lederlon, Leflunomid Gebro, Salazopyrin EN, Spiricort, Xyloneural
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
Time frame: 24 weeks
To compare the efficacy rates of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment
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.
Time frame: 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
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\*
Time frame: weeks 8, 12, 18 and 24
To compare the relative time taken for patients to reach remission across the two treatment groups
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
Time frame: 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
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
Time frame: 24 weeks
To compare the safety and tolerability of CZP between the two treatment groups following 8, 12, 18 and 24 weeks of treatment
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
Time frame: 8, 12, 18 and 24 weeks
To conduct pharmacokinetic analysis to compare the CZP serum levels following 24 weeks of treatment across both of the treatment groups
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)
Time frame: 24 weeks
To compare the development of anti-CZP antibodies following 24 weeks of treatment across both of the treatment groups
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)
Time frame: 24 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Rüdiger B. Müller