Rheumatoid Arthritis Clinical Trial
Official title:
Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
| Verified date | April 2014 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Observational |
Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.
| Status | Completed |
| Enrollment | 4208 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate - Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy Exclusion Criteria: - Hypersensitivity against the drug or one of the other ingredients - Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) - Moderate to severe cardiac insufficiency |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Site Reference ID/Investigator# 35036 | Aachen | |
| Germany | Site Reference ID/Investigator# 35510 | Ahlen | |
| Germany | Site Reference ID/Investigator# 35040 | Ahrensburg | |
| Germany | Site Reference ID/Investigator# 35043 | Altenburg | |
| Germany | Site Reference ID/Investigator# 35046 | Altenholz | |
| Germany | Site Reference ID/Investigator# 35049 | Amberg | |
| Germany | Site Reference ID/Investigator# 35057 | Arnstadt | |
| Germany | Site Reference ID/Investigator# 35520 | Attendorn | |
| Germany | Site Reference ID/Investigator# 33349 | Augsburg | |
| Germany | Site Reference ID/Investigator# 33358 | Bad Abbach | |
| Germany | Site Reference ID/Investigator# 33361 | Bad Abbach | |
| Germany | Site Reference ID/Investigator# 35142 | Bad Aibling | |
| Germany | Site Reference ID/Investigator# 35570 | Bad Brambach | |
| Germany | Site Reference ID/Investigator# 35573 | Bad Bramstedt | |
| Germany | Site Reference ID/Investigator# 33372 | Bad Endbach | |
| Germany | Site Reference ID/Investigator# 33378 | Bad Iburg | |
| Germany | Site Reference ID/Investigator# 33382 | Bad Iburg | |
| Germany | Site Reference ID/Investigator# 33387 | Bad Kreuznach | |
| Germany | Site Reference ID/Investigator# 35575 | Bad Kreuznach | |
| Germany | Site Reference ID/Investigator# 33391 | Bad Liebenwerda | |
| Germany | Site Reference ID/Investigator# 33396 | Bad Muender | |
| Germany | Site Reference ID/Investigator# 102216 | Bad Nauheim | |
| Germany | Site Reference ID/Investigator# 35578 | Bad Neuenahr | |
| Germany | Site Reference ID/Investigator# 33404 | Bad Rappenau | |
| Germany | Site Reference ID/Investigator# 51883 | Bad Salzungen | |
| Germany | Site Reference ID/Investigator# 33412 | Bad Soden-Salmuenster | |
| Germany | Site Reference ID/Investigator# 33425 | Baden-Baden | |
| Germany | Site Reference ID/Investigator# 33429 | Bamberg | |
| Germany | Site Reference ID/Investigator# 33438 | Bautzen | |
| Germany | Site Reference ID/Investigator# 33442 | Bayreuth | |
| Germany | Site Reference ID/Investigator# 33446 | Bayreuth | |
| Germany | Site Reference ID/Investigator# 33620 | Berlin | |
| Germany | Site Reference ID/Investigator# 33641 | Berlin | |
| Germany | Site Reference ID/Investigator# 33648 | Berlin | |
| Germany | Site Reference ID/Investigator# 33658 | Berlin | |
| Germany | Site Reference ID/Investigator# 33661 | Berlin | |
| Germany | Site Reference ID/Investigator# 33670 | Berlin | |
| Germany | Site Reference ID/Investigator# 33674 | Berlin | |
| Germany | Site Reference ID/Investigator# 33683 | Berlin | |
| Germany | Site Reference ID/Investigator# 33687 | Berlin | |
| Germany | Site Reference ID/Investigator# 33690 | Berlin | |
| Germany | Site Reference ID/Investigator# 33693 | Berlin | |
| Germany | Site Reference ID/Investigator# 33697 | Berlin | |
| Germany | Site Reference ID/Investigator# 33704 | Berlin | |
| Germany | Site Reference ID/Investigator# 34238 | Berlin | |
| Germany | Site Reference ID/Investigator# 34246 | Berlin | |
| Germany | Site Reference ID/Investigator# 34269 | Berlin | |
| Germany | Site Reference ID/Investigator# 35089 | Berlin | |
| Germany | Site Reference ID/Investigator# 35527 | Berlin | |
| Germany | Site Reference ID/Investigator# 35550 | Berlin | |
| Germany | Site Reference ID/Investigator# 35551 | Berlin | |
| Germany | Site Reference ID/Investigator# 35597 | Berlin | |
| Germany | Site Reference ID/Investigator# 34266 | Berlin-Buch | |
| Germany | Site Reference ID/Investigator# 34252 | Berlin-Wannsee | |
| Germany | Site Reference ID/Investigator# 35556 | Bernau | |
| Germany | Site Reference ID/Investigator# 34277 | Biberach | |
| Germany | Site Reference ID/Investigator# 35562 | Binzen | |
| Germany | Site Reference ID/Investigator# 34285 | Blankenburg/Hart | |
| Germany | Site Reference ID/Investigator# 34288 | Blaubeuren | |
| Germany | Site Reference ID/Investigator# 34291 | Bocholt | |
| Germany | Site Reference ID/Investigator# 35566 | Bocholt | |
| Germany | Site Reference ID/Investigator# 35641 | Bochum | |
| Germany | Site Reference ID/Investigator# 35644 | Bogen | |
| Germany | Site Reference ID/Investigator# 34296 | Bonn | |
| Germany | Site Reference ID/Investigator# 34302 | Bonn | |
| Germany | Site Reference ID/Investigator# 35646 | Bonn | |
| Germany | Site Reference ID/Investigator# 35652 | Bottrop | |
| Germany | Site Reference ID/Investigator# 34307 | Braunschweig | |
| Germany | Site Reference ID/Investigator# 35603 | Breitenbrunn | |
| Germany | Site Reference ID/Investigator# 35609 | Bremen | |
| Germany | Site Reference ID/Investigator# 35611 | Celle | |
| Germany | Site Reference ID/Investigator# 34699 | Chemnitz | |
| Germany | Site Reference ID/Investigator# 35093 | Chemnitz | |
| Germany | Site Reference ID/Investigator# 35615 | Coesfeld | |
| Germany | Site Reference ID/Investigator# 33989 | Cologne | |
| Germany | Site Reference ID/Investigator# 35237 | Cologne | |
| Germany | Site Reference ID/Investigator# 34708 | Cottbus | |
| Germany | Site Reference ID/Investigator# 34711 | Cottbus | |
| Germany | Site Reference ID/Investigator# 35621 | Darmstadt | |
| Germany | Site Reference ID/Investigator# 34725 | Deggendorf | |
| Germany | Site Reference ID/Investigator# 35631 | Dessau-Rosslau | |
| Germany | Site Reference ID/Investigator# 34742 | Dortmund | |
| Germany | Site Reference ID/Investigator# 35634 | Dortmund | |
| Germany | Site Reference ID/Investigator# 35635 | Dortmund | |
| Germany | Site Reference ID/Investigator# 34748 | Dresden | |
| Germany | Site Reference ID/Investigator# 34751 | Dresden | |
| Germany | Site Reference ID/Investigator# 34754 | Dresden | |
| Germany | Site Reference ID/Investigator# 34760 | Dresden | |
| Germany | Site Reference ID/Investigator# 35170 | Dresden | |
| Germany | Site Reference ID/Investigator# 34768 | Duesseldorf | |
| Germany | Site Reference ID/Investigator# 34773 | Duesseldorf | |
| Germany | Site Reference ID/Investigator# 34778 | Duisburg | |
| Germany | Site Reference ID/Investigator# 34784 | Eberswalde | |
| Germany | Site Reference ID/Investigator# 35184 | Elmshorn | |
| Germany | Site Reference ID/Investigator# 34809 | Erfurt | |
| Germany | Site Reference ID/Investigator# 35096 | Erfurt | |
| Germany | Site Reference ID/Investigator# 35191 | Erfurt | |
| Germany | Site Reference ID/Investigator# 34821 | Erlangen | |
| Germany | Site Reference ID/Investigator# 35196 | Essen | |
| Germany | Site Reference ID/Investigator# 35199 | Essen | |
| Germany | Site Reference ID/Investigator# 35202 | Feldafing | |
| Germany | Site Reference ID/Investigator# 35205 | Flensburg | |
| Germany | Site Reference ID/Investigator# 34833 | Forchheim | |
| Germany | Site Reference ID/Investigator# 35210 | Frankenberg | |
| Germany | Site Reference ID/Investigator# 34840 | Frankfurt | |
| Germany | Site Reference ID/Investigator# 34843 | Frankfurt | |
| Germany | Site Reference ID/Investigator# 34849 | Frankfurt | |
| Germany | Site Reference ID/Investigator# 35213 | Fraureuth | |
| Germany | Site Reference ID/Investigator# 35219 | Freiberg | |
| Germany | Site Reference ID/Investigator# 34854 | Freiburg | |
| Germany | Site Reference ID/Investigator# 34861 | Freiburg | |
| Germany | Site Reference ID/Investigator# 35221 | Freiburg | |
| Germany | Site Reference ID/Investigator# 35101 | Freystadt | |
| Germany | Site Reference ID/Investigator# 35224 | Friedrichroda | |
| Germany | Site Reference ID/Investigator# 34879 | Gelsenkirchen | |
| Germany | Site Reference ID/Investigator# 34883 | Gera | |
| Germany | Site Reference ID/Investigator# 34887 | Giessen | |
| Germany | Site Reference ID/Investigator# 35491 | Gosheim | |
| Germany | Site Reference ID/Investigator# 34896 | Goslar | |
| Germany | Site Reference ID/Investigator# 34901 | Greifswald | |
| Germany | Site Reference ID/Investigator# 34904 | Greifswald | |
| Germany | Site Reference ID/Investigator# 35496 | Greifswald | |
| Germany | Site Reference ID/Investigator# 102217 | Gross Ammensleben | |
| Germany | Site Reference ID/Investigator# 35498 | Guben | |
| Germany | Site Reference ID/Investigator# 34912 | Guestrow | |
| Germany | Site Reference ID/Investigator# 35503 | Hagen | |
| Germany | Site Reference ID/Investigator# 34922 | Halle | |
| Germany | Site Reference ID/Investigator# 34932 | Halle | |
| Germany | Site Reference ID/Investigator# 34937 | Halle | |
| Germany | Site Reference ID/Investigator# 34940 | Halle | |
| Germany | Site Reference ID/Investigator# 34944 | Halle | |
| Germany | Site Reference ID/Investigator# 34952 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34955 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34958 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34961 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34970 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34974 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34983 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34986 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34994 | Hamburg | |
| Germany | Site Reference ID/Investigator# 34998 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35000 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35007 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35111 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35441 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35444 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35449 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35452 | Hamburg | |
| Germany | Site Reference ID/Investigator# 35019 | Hanau | |
| Germany | Site Reference ID/Investigator# 33712 | Hanover | |
| Germany | Site Reference ID/Investigator# 35025 | Hanover | |
| Germany | Site Reference ID/Investigator# 33792 | Harrislee | |
| Germany | Site Reference ID/Investigator# 35459 | Haseluenne | |
| Germany | Site Reference ID/Investigator# 102215 | Heidelberg | |
| Germany | Site Reference ID/Investigator# 33798 | Heidelberg | |
| Germany | Site Reference ID/Investigator# 33801 | Heidelberg | |
| Germany | Site Reference ID/Investigator# 33808 | Heidelberg | |
| Germany | Site Reference ID/Investigator# 35119 | Heidelberg | |
| Germany | Site Reference ID/Investigator# 35464 | Heidenheim | |
| Germany | Site Reference ID/Investigator# 33818 | Heilbad Heiligenstadt | |
| Germany | Site Reference ID/Investigator# 33825 | Herrsching | |
| Germany | Site Reference ID/Investigator# 33834 | Hof | |
| Germany | Site Reference ID/Investigator# 33842 | Hofheim | |
| Germany | Site Reference ID/Investigator# 33845 | Hohenfelde | |
| Germany | Site Reference ID/Investigator# 33855 | Illertissen | |
| Germany | Site Reference ID/Investigator# 33858 | Immenstadt | |
| Germany | Site Reference ID/Investigator# 35479 | Ingolstadt | |
| Germany | Site Reference ID/Investigator# 51882 | Jena | |
| Germany | Site Reference ID/Investigator# 33942 | Juelich | |
| Germany | Site Reference ID/Investigator# 33946 | Kahla | |
| Germany | Site Reference ID/Investigator# 35125 | Kahla | |
| Germany | Site Reference ID/Investigator# 33950 | Kaiserslautern | |
| Germany | Site Reference ID/Investigator# 33956 | Karlsruhe | |
| Germany | Site Reference ID/Investigator# 33961 | Karlsruhe | |
| Germany | Site Reference ID/Investigator# 33964 | Kassel | |
| Germany | Site Reference ID/Investigator# 34002 | Koenigs Wusterhausen | |
| Germany | Site Reference ID/Investigator# 34008 | Kressbronn | |
| Germany | Site Reference ID/Investigator# 34084 | Kronach | |
| Germany | Site Reference ID/Investigator# 34005 | Lahr | |
| Germany | Site Reference ID/Investigator# 35245 | Landau | |
| Germany | Site Reference ID/Investigator# 34100 | Leipzig | |
| Germany | Site Reference ID/Investigator# 34106 | Leipzig | |
| Germany | Site Reference ID/Investigator# 34109 | Leipzig | |
| Germany | Site Reference ID/Investigator# 34112 | Leipzig | |
| Germany | Site Reference ID/Investigator# 35254 | Lippstadt | |
| Germany | Site Reference ID/Investigator# 35306 | Ludwigsfelde | |
| Germany | Site Reference ID/Investigator# 35262 | Ludwigshafen | |
| Germany | Site Reference ID/Investigator# 34136 | Luebeck | |
| Germany | Site Reference ID/Investigator# 34139 | Lueneburg | |
| Germany | Site Reference ID/Investigator# 34147 | Magdeburg | |
| Germany | Site Reference ID/Investigator# 34150 | Magdeburg | |
| Germany | Site Reference ID/Investigator# 35276 | Mainz | |
| Germany | Site Reference ID/Investigator# 34192 | Marktredwitz | |
| Germany | Site Reference ID/Investigator# 34196 | Marl | |
| Germany | Site Reference ID/Investigator# 34200 | Meissen | |
| Germany | Site Reference ID/Investigator# 35285 | Menz | |
| Germany | Site Reference ID/Investigator# 35287 | Minden | |
| Germany | Site Reference ID/Investigator# 34208 | Mittelherwigsdorf | |
| Germany | Site Reference ID/Investigator# 34213 | Moenchengladbach | |
| Germany | Site Reference ID/Investigator# 34218 | Moenchengladbach | |
| Germany | Site Reference ID/Investigator# 34221 | Moenkeberg | |
| Germany | Site Reference ID/Investigator# 34224 | Muehlhausen | |
| Germany | Site Reference ID/Investigator# 35292 | Muelheim | |
| Germany | Site Reference ID/Investigator# 34229 | Muellheim | |
| Germany | Site Reference ID/Investigator# 34048 | Muenster | |
| Germany | Site Reference ID/Investigator# 34040 | Munich | |
| Germany | Site Reference ID/Investigator# 34043 | Munich | |
| Germany | Site Reference ID/Investigator# 34232 | Munich | |
| Germany | Site Reference ID/Investigator# 34235 | Munich | |
| Germany | Site Reference ID/Investigator# 35295 | Munich | |
| Germany | Site Reference ID/Investigator# 35298 | Munich | |
| Germany | Site Reference ID/Investigator# 34052 | Naunhof | |
| Germany | Site Reference ID/Investigator# 34061 | Neubrandenburg | |
| Germany | Site Reference ID/Investigator# 34064 | Neuburg | |
| Germany | Site Reference ID/Investigator# 34071 | Neumuenster | |
| Germany | Site Reference ID/Investigator# 35313 | Neuss | |
| Germany | Site Reference ID/Investigator# 34076 | Neustadt | |
| Germany | Site Reference ID/Investigator# 35321 | Niederbrombach | |
| Germany | Site Reference ID/Investigator# 34080 | Niefern-Oeschelbronn | |
| Germany | Site Reference ID/Investigator# 34158 | Nienburg | |
| Germany | Site Reference ID/Investigator# 34173 | Oelsnitz | |
| Germany | Site Reference ID/Investigator# 34176 | Offenburg | |
| Germany | Site Reference ID/Investigator# 33492 | Oldenburg | |
| Germany | Site Reference ID/Investigator# 34718 | Ostseebad Damp | |
| Germany | Site Reference ID/Investigator# 35335 | Paderborn | |
| Germany | Site Reference ID/Investigator# 33508 | Parchim | |
| Germany | Site Reference ID/Investigator# 35340 | Passau | |
| Germany | Site Reference ID/Investigator# 33517 | Pfullendorf | |
| Germany | Site Reference ID/Investigator# 67482 | Pirna | |
| Germany | Site Reference ID/Investigator# 33523 | Planegg | |
| Germany | Site Reference ID/Investigator# 33528 | Plauen | |
| Germany | Site Reference ID/Investigator# 33466 | Potsdam | |
| Germany | Site Reference ID/Investigator# 33470 | Potsdam | |
| Germany | Site Reference ID/Investigator# 33476 | Pruem | |
| Germany | Site Reference ID/Investigator# 33479 | Puettlingen | |
| Germany | Site Reference ID/Investigator# 33484 | Radebeul | |
| Germany | Site Reference ID/Investigator# 35347 | Radebeul | |
| Germany | Site Reference ID/Investigator# 35136 | Ratingen | |
| Germany | Site Reference ID/Investigator# 33488 | Ratzeburg | |
| Germany | Site Reference ID/Investigator# 33883 | Regensburg | |
| Germany | Site Reference ID/Investigator# 33886 | Regensburg | |
| Germany | Site Reference ID/Investigator# 33890 | Regensburg | |
| Germany | Site Reference ID/Investigator# 33897 | Reken | |
| Germany | Site Reference ID/Investigator# 33902 | Rendsburg | |
| Germany | Site Reference ID/Investigator# 33907 | Rheine | |
| Germany | Site Reference ID/Investigator# 35355 | Rickenbach | |
| Germany | Site Reference ID/Investigator# 33911 | Riesa | |
| Germany | Site Reference ID/Investigator# 33914 | Rinteln | |
| Germany | Site Reference ID/Investigator# 33923 | Rostock | |
| Germany | Site Reference ID/Investigator# 33927 | Rostock | |
| Germany | Site Reference ID/Investigator# 33931 | Rothenburg | |
| Germany | Site Reference ID/Investigator# 35362 | Ruedersdorf | |
| Germany | Site Reference ID/Investigator# 34016 | Saarbruecken | |
| Germany | Site Reference ID/Investigator# 34023 | Salzwedel | |
| Germany | Site Reference ID/Investigator# 34027 | Sande | |
| Germany | Site Reference ID/Investigator# 33534 | Schneeberg | |
| Germany | Site Reference ID/Investigator# 33539 | Schramberg | |
| Germany | Site Reference ID/Investigator# 33542 | Schutterwald | |
| Germany | Site Reference ID/Investigator# 35371 | Schwandorf | |
| Germany | Site Reference ID/Investigator# 33549 | Schwerin | |
| Germany | Site Reference ID/Investigator# 35376 | Schwerin | |
| Germany | Site Reference ID/Investigator# 33555 | Schwerte | |
| Germany | Site Reference ID/Investigator# 33559 | Seesen | |
| Germany | Site Reference ID/Investigator# 33563 | Senden | |
| Germany | Site Reference ID/Investigator# 35380 | Singen | |
| Germany | Site Reference ID/Investigator# 33567 | Sinsheim | |
| Germany | Site Reference ID/Investigator# 33572 | Soltau | |
| Germany | Site Reference ID/Investigator# 33577 | Spremberg | |
| Germany | Site Reference ID/Investigator# 35383 | St. Martin | |
| Germany | Site Reference ID/Investigator# 33588 | Stadthagen | |
| Germany | Site Reference ID/Investigator# 33592 | Steinhagen | |
| Germany | Site Reference ID/Investigator# 33598 | Stuttgart | |
| Germany | Site Reference ID/Investigator# 33604 | Stuttgart | |
| Germany | Site Reference ID/Investigator# 33607 | Stuttgart | |
| Germany | Site Reference ID/Investigator# 33611 | Stuttgart | |
| Germany | Site Reference ID/Investigator# 35389 | Suhl | |
| Germany | Site Reference ID/Investigator# 35391 | Tegernau | |
| Germany | Site Reference ID/Investigator# 33625 | Torgelow | |
| Germany | Site Reference ID/Investigator# 33637 | Ueberlingen-Nussdorf | |
| Germany | Site Reference ID/Investigator# 35395 | Uffenheim | |
| Germany | Site Reference ID/Investigator# 33721 | Ulm | |
| Germany | Site Reference ID/Investigator# 33724 | Ulm | |
| Germany | Site Reference ID/Investigator# 33734 | Viersen | |
| Germany | Site Reference ID/Investigator# 33737 | Villingen-Schwenningen | |
| Germany | Site Reference ID/Investigator# 35397 | Voehringen | |
| Germany | Site Reference ID/Investigator# 33742 | Waltrop | |
| Germany | Site Reference ID/Investigator# 33749 | Weener | |
| Germany | Site Reference ID/Investigator# 33751 | Weissenfels | |
| Germany | Site Reference ID/Investigator# 33852 | Welzow | |
| Germany | Site Reference ID/Investigator# 35404 | Wiefelstede | |
| Germany | Site Reference ID/Investigator# 33761 | Wiesbaden | |
| Germany | Site Reference ID/Investigator# 33765 | Wiesbaden | |
| Germany | Site Reference ID/Investigator# 35408 | Wiesbaden | |
| Germany | Site Reference ID/Investigator# 35413 | Wiesbaden | |
| Germany | Site Reference ID/Investigator# 33772 | Wilhelmshaven | |
| Germany | Site Reference ID/Investigator# 33780 | Wittlich | |
| Germany | Site Reference ID/Investigator# 33718 | Wuerzburg | |
| Germany | Site Reference ID/Investigator# 35420 | Wuppertal | |
| Germany | Site Reference ID/Investigator# 33864 | Zerbst | |
| Germany | Site Reference ID/Investigator# 33867 | Zeven | |
| Germany | Site Reference ID/Investigator# 33873 | Zwickau | |
| Germany | Site Reference ID/Investigator# 33876 | Zwickau | |
| Germany | Site Reference ID/Investigator# 33880 | Zwiesel |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Score (DAS) 28 | The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Primary | Percentage of Participants in DAS28 Remission | Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. | Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Percentage of Participants With a Significant Therapeutic Response | Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of = 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. |
Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Percentage of Participants With Low, Moderate and High Disease Activity | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score = 3.2; Moderate disease activity as a DAS28 >3.2 to =5.1; High disease activity as a DAS28 >5.1. |
Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Erythrocyte Sedimentation Rate (ESR) Over Time | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | C-Reactive Protein (CRP) Levels Over Time | C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Tender Joint Count (TJC) Over Time | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Swollen Joint Count (SJC) Over Time | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Hannover Functional Questionnaire (FFbH) Over Time | A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) รท 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity. |
Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Patients Global Assessment of Disease Activity Over Time | Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Months 3, 6, 9, 12, 18 and 24 | No |
| Secondary | Participants Assessment of Fatigue Over Time | Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Month 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Participants Assessment of Pain Over Time | Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Secondary | Percentage of Participants With Impairment in Daily Activities | Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks. | Baseline and Months 3, 6, 9, 18, and 24 | No |
| Secondary | Number of Days Missed From Work Due to Rheumatoid Arthritis | Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months. | Baseline and Months 6, 12, 18, and 24 | No |
| Secondary | Percentage of Participants With In-patient Hospitalization | The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months. | Month 6, 12, 18, and 24 | No |
| Secondary | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Baseline and Months 3, 6, 9, 12, 18, and 24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
| Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
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