Observation of Treatment With Certolizumab Pegol in Daily Practice

Rheumatoid Arthritis Clinical Trial

— FasT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069419
• Other study ID #: RA0027
• Status: Completed
• Phase: N/A
• First received: February 15, 2010
• Last updated: October 6, 2015
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1117
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

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