natgillin/translations-raw huggingface dataset:
I kontrollerede og åbne forsøg med Trudexa blev der rapporteret alvorlige infektioner (herunder mi
In controlled and open label studies with Trudexa, serious infections (including fatal infections, which
De fleste ge
au occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
Læ
Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of
Maligniteter og lymfeproliferative sygdomme
r ge latent disease.
11 I de kontrollerede dele af ti Trudexa- forsøg af mindst 12 ugers varighed (I- IX og CHARM) hos patienter med moderat til svær aktiv reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og
Malignancies and lymphoproliferative disorders lon During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among no
1000 patient- år blandt 1570 kontrolpatienter (gennemsnitlig varighed af behandlingen var 5. 7 måneder for Trudexa og 5. 5 måneder for de kontro- lbehandlede patienter).
2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for control- treated patients).
Hyppigheden (95% konfidensinterval) af ikke- melanom
The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years t
til hudkræft var 7, 6 (4, 7, 12, 4) pr.
among control patients.
1000 patient- år blandt de
Of these skin cancers, squamous cell carcinomas occurred at rates (95% uc
1000 patient- år blandt kontrolpatienterne.
confidence interval) of 2.4 (1.0, 5.7) per 1000 patient-years among Trudexa-treated patients and 0 per 1000 patient-years among control patients.
Hyppigheden (95% konfidensinterval) af lymfomer var 1. 0 (0, 2, 3, 8) pr.
The rate (95% confidence interval) of lymphomas was 1.0 rod
tor melanom hudkræft, cirka 13. 6 pr.
(0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patient- years among control patients.
1000 patient år.
The observed rate of non- melanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of na
1000 patient- år.
lymphomas is approximately 1.2 per 1000 patient years.
au Der er ved post- marketing erfaring fra januar 2003, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af andre maligniteter end lymfomer og ikke- melanom hudkræft på cirka 1, 7 pr.
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, i dic
Den rapporterede hyppighed af ikke- melanom hudkræft og lymfomer er henholdsvis cirka 0, 2 og 0, 4 pr.
the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
1000 patient- år (se pkt.
Me
4. 4).. re Autoantistoffer ge
Autoantibodies
Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit forsøgne I- V.
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I− V.
kontrolbehandlede patienter med negative antinukleære antistoftitere ved baseline positive titere efter 24 uger.
In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control− treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Ingen patienter udviklede lupus nefrit l
The patients
eller symptomer i centralnervesystemet. ke
No patients developed lupus nephritis or central nervous system symptoms.
I de kontrollerede kliniske reumatoid artrit- forsøg (forsøg I- IV) var r ik
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I− IV),
forhøjelsen i ALAT- værdierne hos patienter behandlet med adalimumab og placebo ens.
ed elevations of ALT were similar in patients receiving adalimumab or placebo.
Hos patienter med tidlig reumatoid artrit (sygdomsvarighed på mindre end 3 år) (forsøg 5) forekom forhøjede ALAT- værdier oftere i kombinationsarmen (Trudexa/ methotrexat) end i methotrexat - te
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (Study V), elevations of ALT were more common in the combination arm (Trudexa / methotrexate) compared to the methotrexate monotherapy
monoterapiarmen eller Trudexa- monoterapiarmen.
ris arm or the Trudexa monotherapy arm.
Forhøjede ALAT- værdier forekom oftere hos patienter med psoriasisartrit dle
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients
(forsøg VI- VII) end hos patienter med reumatoid artrit i kliniske forsøg.
tho (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
I alle forsøg (I- VII) var patienter med forhøjede ALAT- værdier asymptomatiske, og i de fleste tilfælde var forhøjelserne forbigående og forsvandt ved fortsat behandling. mi
In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Kliniske forsøg med Crohns sygdom: i kontrollererde kliniske forsøg var forhøjelse af ALAT sammenlignelig hos patienter, der modtog adalimumab eller placebo. ge
au Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Yderligere bivirkninger fra overvågning efter markedsføring og kliniske fase IV- forsøg Læ
r Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
12 Tabel 2 Uønskede virkninger iovervågning efter markedsføring og kliniske fase IV- forsøg
ge The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials: lon Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies no
sa Sygdomme i lever og galdeveje Sygdomme i nervesystemet
System Organ Class Hepatobiliary Disorders Nervous system disorders Respiratory, thoracic and mediastinal disorders t uc
reaktivering af hepatitis B demyeliniserende sygdomme (f. eks. optisk neuritis)
Adverse Reaction reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis) interstitial lung disease, including pulmonary
til Sygdomme i åndedrætsorganer, brysthule og mediastinum Sygdomme i hud og subkutant væv
fibrosis Skin and subcutaneous tissue disorders Immune system disorders rod
ret Forstyrrelser i immunsystemet
cutaneous vasculitis anaphylaxis
Anafylaksi
4.9 Overdose lP
tor Der blev ikke observeret nogen dosisbegrænsende toksicitet i kliniske undersøgelser.
No dose-limiting toxicity was observed during clinical trials.
Det højeste dosisniveau, som er evalueret, har været adskillige intravenøse doser på 10 mg/ kg.
The highest dose level evaluated has been multiple intravenous doses of 10 mg/ kg. na
au 5.
5.
5. 1 Farmakodynamiske egenskaber re Farmakoterapeutisk klassifikation:
5.1 Pharmacodynamic properties i dic
L04AA17 ge
L04AA17
Virkningsmekanisme æn
Mechanism of action Me
ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM - 1, VCAM- 1 og ICAM- 1 med en IC50 på 1- 2 x 10- 10 M). ke
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).
Farmakodynamiske virkninger r ik
12 Pharmacodynamic effects
Efter behandling med Trudexa blev der hos patienter med reumatoid artrit observeret et hurtigt fald i niveauet af inflammatoriske akutfasereaktanter (C- reaktivt protein (CRP) og erytrocytsænkningshastighed (ESR)) og serumcytokiner (IL- 6) sammenholdt med baseline. te
After treatment with Trudexa, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis.
Serumniveauer af matrixmetalloproteinaser (MMP- 1 og MMP- 3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter Trudexa- administration.
ed destruction were also decreased after Trudexa administration.
Hæmatologiske tegn på kronisk inflammation forbedredes sædvanligvis hos patienter behandlet med dle
Patients treated with Trudexa usually experienced improvement in haematological signs of chronic inflammation.
Der blev også fundet et hurtigt fald i CRP hos patienter med Crohns sygdom. mi
ris A rapid decrease in CRP levels was also observed in patients with Crohn’ s disease.
Reumatoid artrit ge
tho Rheumatoid arthritis
Trudexa er vurderet hos mere end 3000 patienter i de kliniske reumatoid artrit forsøg.
Some patients
Nogle patienter blev behandlet i op til 60 måneder.
au were treated for up to 60 months duration.
reumatoid artrit blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede forsøg.
The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
13 Forsøg I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18
Doser på
r ge years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
sa 20, 40 eller 80 mg Trudexa eller placebo blev givet hver anden uge i 24 uger.
Doses of 20, 40 or 80 mg of Trudexa or placebo were given every other week for 24 weeks. lon Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Forsøg II evaluerede 544 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit,
Doses of 20 or 40 mg of Trudexa were given by subcutaneous injection every other week with placebo on no
Ingen andre
alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
ret sygdomsmodificerende antireumatiske lægemidler blev tilladt.
No other disease-modifying anti-rheumatic drugs were allowed.
Forsøg III evaluerede 619 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit,
Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 t uc
ise hvor methotrexat i doser på 12, 5 til 25 mg (10 mg ved methotrexat- intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat- dosen forblev konstant på 12, 5 til 25 mg hver uge.
years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate- intolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Den første fik placeboinjektioner hver uge i 52 uger.
The first received placebo injections every week for 52 weeks. rod
Derefter blev patienterne optaget i et åbent forlængelsesforsøg hvor 40 mg Trudexa blev administreret hver anden uge i op til 60 måneder.
Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Trudexa was administered every other week up to 60 months. lP
au Forsøg IV vurderede primært sikkerheden hos 636 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit.
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Det var tilladt for patienterne at være enten fri for sygdomsmodificerende antireumatisk lægemiddel eller at forblive i deres allerede eksisterende reumatologiske terapi, forudsat at terapien havde været stabil i mindst 28 dage.
anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Disse terapier omfatter methotrexat, leflunomid, re hydrozychloroquine, sulfasalazin og/ eller guldsalte.
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/ or gold salts.
Patienterne blev randomiseret til 40 mg Trudexa eller placebo hver anden uge i 24 uger. ge
or placebo every other week for 24 weeks. dic
Forsøg V vurderede 799 methotrexat- naive voksne patienter med moderat til alvorlig aktiv reumatoid artrit i tidligt stadium (gennemsnitlig sygdomsvarighed på mindre end 9 måneder).
Study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Dette forsøg æn
This study evaluated the efficacy of Me
vurderede virkningen af Trudexa 40 mg hver anden uge/ methotrexat- kombinationsterapi, Trudexa monoterapi 40 mg hver anden uge og methotrexat- monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger. l
Trudexa 40 mg every other week/ methotrexate combination therapy, Trudexa 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
af patienter, som fik ACR 20- respons i uge 24 eller 26.
The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Det primære end- point i forsøg V var procentdelen af patienter, som opnåede et ACR 50 respons i uge 52.
The primary endpoint in Study V was the percent of patients who achieved an ACR 50 response at week 52.
Forsøgne III og V havde yderligere primære end- points i uge 52 med forsinket sygdomsprogression (bestemt ud fra r ik
Study III and V had an
røntgenresultater).
13 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Forsøg III havde også et primært end- point, som var ændringer i livskvalitet.
Study III also had a primary endpoint of changes in quality of life.
ACR respons te
ACR response
Den procent af Trudexa- behandlede patienter, der fik ACR 20 -, 50 - og 70- respons, var konsistent mellem forsøg I, II og III.
The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across
Resultaterne for 40 mg hver anden uge er opstillet i tabel 3. dle mi ge Læ
The results for the 40 mg every other week dose are summarised in Table 3.
14 Tabel 3:
Table 3:
ACR- respons i placebokontrollerede forsøg (Procent af patienter)
ACR Responses in Placebo-Controlled Trials
lg
ris (Percent of Patients)
Forsøg Ia **
Study Ia**
Forsøg IIa **
Study IIa**
Forsøg IIIa **
Study IIIa**
sa
tho
Trudexab / MTXc Placebo Trudexab Placebo / n=63 n=110 n=113 MTXc
Trudexab/ MTXc Placebo Trudexab Placebo/ n=63 n=110 n=113 MTXc n=200
Trudexab / MTXc
Trudexab/ MTXc n=207
46, 0%
13.3% NA
29, 5%
65.1% NA
63, 3%
19.1% NA
NA NA NA NA
46.0% NA
24, 0%
29.5% 24.0%
58, 9%
63.3% 58.9%
måneder ACR 50
r ACR 50
ise
ge
6 måneder 12
6 months 12 months
måneder ACR 70
ACR 70 lon a
måneder
**p < 0.01, Trudexa versus placebo
au a Forsøg I efter 24 uger, Forsøg II efter 26 uger og Forsøg III efter 24 og 52 uger b 40 mg Trudexa givet hver anden uge c MTX = methotrexat re ** p < 0, 01, Trudexa over for placebo
In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen t
I forsøg I- IV forbedredes alle individuelle komponenter af ACR- responskriterierne (antal af ømme og ge
joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores uc
hævede led, læge - og patientvurderinger af sygdomsaktivitet og smerter, fysisk funktionsevneindeksværdier (HAQ) og CRP (mg/ dl) - værdier) efter 24 eller 26 uger sammenlignet med placebo.
and CRP (mg/ dl) values) improved at 24 or 26 weeks compared to placebo.
I tillæg hertil blev behandlingseffekt æn
There rod
Der var 114 ud af 207 patienter, som fortsatte med Trudexa 40 mg hver anden uge i 60 måneder.
were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months.
Blandt disse havde 86, 72 og 41 patienter ACR response på henholdvis 20/ 50/ 70 ved 60 måneder. l ke
Among those, 86, 72, and 41 patients had ACR 20/ 50/ 70 response, respectively at month 60.
I forsøg IV var ACR 20- respons for patienter behandlet med Trudexa plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0, 001). r ik
statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
I forsøgne I- IV opnåede Trudexa- behandlede patienter statistisk signifikant ACR 20 - og 50- respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses na
I forsøg V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat- naive, førte te
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy i
kombinationsbehandlingen med Trudexa og methotrexat til hurtigere og signifikant større ACR respons end methotrexat- monoterapi og Trudexa- monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 4). dle
Me
ACR Respons i studie V (Procentdel af patienter) mi
ACR Responses in Study V (percent of patients)
Respons ge
Response
n=268 ACR 20 Læ
n=268 ACR 20
Uge 52
Week 52 Week 104
0, 043
0.043 0.140
Uge 104 50
ACR 50
lg ACR 70
ACR 70
27, 2% 28, 4%
27.2% 28.4%
25, 9% 28, 1%
25.9% 28.1%
45, 5% 46, 6%
45.5% 46.6%
sa a. p- værdi for den parvise sammenligning af methotrexat- monoterapi og Trudexa/ methotrexat - kombinationeterapi ved anvendelse af Mann- Whitney U test. b. p- værdi for den parvise sammenligning af Trudexa- monoterapi og Trudexa/ methotrexat -
a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate
til kombinationsterapi ved anvendelse af Mann- Whitney U test c. p- værdi for den parvise sammenligning af Trudexa- monoterapi og methotrexat- monoterapi ved anvendelse af Mann- Whitney U test
ris combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
ret I uge 52 opnåede 42, 9% af patienterne, som fik Trudexa/ methotrexat- kombinationsterapi, klinisk remission (DAS28 < 2, 6) sammenlignet med 20, 6% af patienterne, som fik methotrexat- monoterapi
tho combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
ise og 23, 4% af patienterne, som fik Trudexa- monoterapi.
au At week 52, 42.9% of patients who received Trudexa/ methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy.
Trudexa/ methotrexat- kombinationsterapi var klinisk og statistisk bedre end methotrexat- monoterapi (p < 0, 001) og Trudexa- monoterapi (p < 0, 001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy
Responset i de to monoterapi- arme var ens (p=0, 447).
r (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe
tor Radiografisk respons
The response for the two monotherapy arms was similar (p = 0.447).
au I forsøg III, hvor de Trudexa- behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i den totale modificerede Sharpscore og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
Radiographic response lon In Study III, where Trudexa treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Der blev observeret en significant mindre radiografisk progression hos Trudexa - / methotrexat - re patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 5).
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than no
strukturel ødelæggelse opretholdes i 60 måneder i en delmængde af patienterne.
Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
133/ 127 patienter, der oprindeligt blev behandlet med 40 mg Trudexa hver anden uge, blev radiografisk evalueret ved 5 år.
113/ 207 of patients originally treated with 40 mg Humira every t
Blandt disse viste 66 patienter ingen af progression af strukturel ødelæggelse defineret som æn
Among those, 66 patients showed no uc
ændring af TSS på nul eller mindre.
progression of structural damage defined by a change in the TSS of zero or less.
Gennemsnitlige radiografiske ændringer gennem 12 måneder i Forsøg III l
Radiographic Mean Changes Over 12 Months in Study III rod
Placebo / MTXa ke
Placebo/
TRUDEXA/ MTX
TRUDEXA/ MTX
Placebo/ MTX -
Placebo/ MTX-
r ik
lP
40 mg
MTXa
hver anden uge
40 mg every other week
TRUDEXA/ MTX (95% konfidensintervalb)
TRUDEXA/ MTX (95% Confidence
a
Intervalb)
Total Sharp- score Erosion score JSNd score
Total Sharp score Erosion score na
2, 6 (1, 4, 3, 8) < 0, 001c 1, 6 (0, 9, 2, 2) < 0, 001 0, 9 (0, 3, 1, 4) 0, 002
< 0.001c < 0.001
methotrexat te
0.9 (0.3, 1.4)
b 95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og Trudexa. c Baseret på ranganalyse d Ledspalteforsnævring dle
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Trudexa. i
I forsøg V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i den modificrede totale Sharp score (se tabel 6). mi
modified total Sharp score (see Table 6).
Gennemsnitlige radiografiske ændringer i uge 52 i forsøg V ge
Radiographic Mean Changes at Week 52 in Study V
Læ
Trudexa/ MT
(95% konfidens - (95% konfidens -
(95% confidence
n=268
interval)
interval) interval)
interval)
Erosion score JSN score
Erosion score JSN score
sa kombinationsbehandling ved anvendelse af Mann- Whitney U test. b. p- værdien for den parvise sammenligning af Trudexa monoterapi og Trudexa/ methotrexat - kombinationsbehandling ved anvendelse af Mann- Whitney U test
ed a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
til c. p- værdien for den parvise sammenligning af Trudexa monoterapi og methotrexat - monoterapi ved anvendelse af Mann- Whitney U test
ris combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test