Observation of Treatment With Certolizumab Pegol in Daily Practice (FasT)

A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients

This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

Detailed Description

The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.

• Study Type: Observational
• Enrollment (Actual): 1117

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany
    • 174
  • Amberg, Germany
    • 70
  • Attendorn, Germany
    • 122
  • Augsburg, Germany
    • 153
  • Bad Aibling, Germany
    • 3
  • Bad Bramstedt, Germany
    • 133
  • Bad Buchau, Germany
    • 167
  • Bad Doberan, Germany
    • 20
  • Bad Endbach, Germany
    • 166
  • Bad Iburg, Germany
    • 8
  • Bad Kissingen, Germany
    • 66
  • Bad Kreuznach, Germany
    • 137
  • Bad Liebenwerda, Germany
    • 119
  • Bad Nauheim, Germany
    • 4
  • Bad Neuenahr-Ahrweiler, Germany
    • 13
  • Bad Staffelstein, Germany
    • 87
  • Baden Baden, Germany
    • 173
  • Bamberg, Germany
    • 19
  • Bautzen, Germany
    • 115
  • Bayreuth, Germany
    • 21
  • Bayreuth, Germany
    • 58
  • Berlin, Germany
    • 163
  • Berlin, Germany
    • 43
  • Berlin, Germany
    • 12
  • Berlin, Germany
    • 25
  • Berlin, Germany
    • 1
  • Berlin, Germany
    • 112
  • Berlin, Germany
    • 179
  • Berlin, Germany
    • 26
  • Berlin, Germany
    • 54
  • Berlin, Germany
    • 59
  • Berlin, Germany
    • 61
  • Berlin, Germany
    • 72
  • Berlin, Germany
    • 78
  • Berlin, Germany
    • 91
  • Berlin, Germany
    • 95
  • Chemnitz, Germany
    • 28
  • Chemnitz, Germany
    • 75
  • Darmstadt, Germany
    • 134
  • Darmstadt, Germany
    • 71
  • Deggendorf, Germany
    • 125
  • Dresden, Germany
    • 131
  • Dresden, Germany
    • 36
  • Dresden, Germany
    • 88
  • Dresden, Germany
    • 98
  • Duisburg, Germany
    • 49
  • Düsseldorf, Germany
    • 46
  • Elmshorn, Germany
    • 102
  • Erfurt, Germany
    • 83
  • Erlangen, Germany
    • 2
  • Essen, Germany
    • 37
  • Essen, Germany
    • 84
  • Frankenberg-Sachsen, Germany
    • 136
  • Frankfurt, Germany
    • 103
  • Frankfurt, Germany
    • 53
  • Freiberg, Germany
    • 29
  • Freiburg, Germany
    • 86
  • Fulda, Germany
    • 77
  • Goslar, Germany
    • 15
  • Greifswald, Germany
    • 135
  • Gräfelfing, Germany
    • 89
  • Guestrow, Germany
    • 107
  • Göttingen, Germany
    • 100
  • Hagen, Germany
    • 157
  • Haldensleben, Germany
    • 150
  • Halle, Germany
    • 11
  • Hamburg, Germany
    • 116
  • Hamburg, Germany
    • 128
  • Hamburg, Germany
    • 139
  • Hamburg, Germany
    • 175
  • Hamburg, Germany
    • 50
  • Hamburg, Germany
    • 55
  • Hamburg, Germany
    • 67
  • Hamburg, Germany
    • 6
  • Hanau, Germany
    • 129
  • Hannover, Germany
    • 159
  • Hannover, Germany
    • 171
  • Hannover, Germany
    • 17
  • Heidelberg, Germany
    • 138
  • Heidelberg, Germany
    • 146
  • Heidelberg, Germany
    • 47
  • Heilbad Heiligenstadt, Germany
    • 92
  • Herrsching, Germany
    • 64
  • Hildesheim, Germany
    • 5
  • Hofheim, Germany
    • 30
  • Hoyerswerda, Germany
    • 48
  • Karlsruhe, Germany
    • 130
  • Karlsruhe, Germany
    • 56
  • Karlsruhe, Germany
    • 96
  • Karlstadt, Germany
    • 101
  • Kassel, Germany
    • 121
  • Katzhuette, Germany
    • 161
  • Kiel, Germany
    • 158
  • Köln, Germany
    • 16
  • Köln, Germany
    • 73
  • Köln, Germany
    • 97
  • Leipzig, Germany
    • 127
  • Ludwigsfelde, Germany
    • 51
  • Ludwigslust, Germany
    • 140
  • Lübeck, Germany
    • 93
  • Magdeburg, Germany
    • 68
  • Mainz, Germany
    • 145
  • Marktredwitz, Germany
    • 31
  • Mittelherwigsdorf, Germany
    • 94
  • Mönchengladbach, Germany
    • 18
  • Mühlheim an der Ruhr, Germany
    • 104
  • München, Germany
    • 10
  • München, Germany
    • 164
  • München, Germany
    • 178
  • München, Germany
    • 9
  • Münster, Germany
    • 113
  • Münster, Germany
    • 123
  • Naunhof, Germany
    • 57
  • Neubrandenburg, Germany
    • 32
  • Neuburg, Germany
    • 108
  • Neuruppin, Germany
    • 149
  • Neuss, Germany
    • 44
  • Nienburg, Germany
    • 7
  • Norderstedt, Germany
    • 141
  • Nürnberg, Germany
    • 172
  • Nürnberg, Germany
    • 22
  • Oberammergau, Germany
    • 99
  • Oberhausen, Germany
    • 23
  • Offenburg, Germany
    • 33
  • Osnabrück, Germany
    • 38
  • Paderborn, Germany
    • 154
  • Pirna, Germany
    • 34
  • Planegg, Germany
    • 81
  • Plauen, Germany
    • 85
  • Potsdam, Germany
    • 27
  • Potsdam, Germany
    • 35
  • Ratingen, Germany
    • 24
  • Rendsburg, Germany
    • 82
  • Rheine, Germany
    • 124
  • Rostock, Germany
    • 109
  • Rostock, Germany
    • 76
  • Rüdersdorf, Germany
    • 90
  • Saarbrücken, Germany
    • 39
  • Salzwedel, Germany
    • 69
  • Schramberg-Sulgen, Germany
    • 117
  • Schwerin, Germany
    • 143
  • Schwerte, Germany
    • 142
  • Seesen, Germany
    • 120
  • Stadtbergen, Germany
    • 105
  • Stuttgart, Germany
    • 14
  • Stuttgart, Germany
    • 40
  • Traunstein, Germany
    • 160
  • Treuenbrietzen, Germany
    • 170
  • Tübingen, Germany
    • 41
  • Uffenheim, Germany
    • 168
  • Ulm, Germany
    • 111
  • Ulm, Germany
    • 65
  • Villingen-Schwenningen, Germany
    • 52
  • Weener, Germany
    • 106
  • Weiden, Germany
    • 162
  • Weißenfels, Germany
    • 177
  • Wiesbaden, Germany
    • 118
  • Wiesbaden, Germany
    • 74
  • Winsen, Germany
    • 60
  • Würselen, Germany
    • 165
  • Würzburg, Germany
    • 152
  • Zeven, Germany
    • 110
  • Zwiesel, Germany
    • 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.

Description

Inclusion Criteria:

• Patients eligible for treatment with Cimzia as defined in EU approved SmPC

Exclusion Criteria:

• Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cimzia; All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6	The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: DAS28 < 2.6: clinical remission; DAS28 from 2.6 to ≤ 3.2: low disease activity; DAS28 from > 3.2 to 5.1: moderate disease activity; DAS28 > 5.1: high disease activity	From Baseline to Visit 9 (around Week 104)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)	Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).	From Baseline to Visit 9 (around Week 104)
Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)	The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).	From Baseline to Visit 9 (around Week 104)
Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)	The CDAI was calculated with the equation: CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).	From Baseline to Visit 9 (around Week 104)

Collaborators and Investigators

• Sponsor: UCB Pharma GmbH

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 15, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Cimzia; Certolizumab Pegol
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RA0027