FrancophonIA/ELRC3.0 huggingface dataset:
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Revlimid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: On 20 June 2012, Celgene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Revlimid, to extend its use to the treatment of patients with newly diagnosed multiple myeloma.
Slovenian: Družba Celgene Europe Ltd. je 20. junija 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Revlimid, s katero je želela uporabo zdravila razširiti na zdravljenje bolnikov z na novo diagnosticiranim multiplim mielomom.
English: The full European Public Assessment Report for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila za zdravilo Revlimid je na voljo na strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Revlimid is an anticancer medicine.
Slovenian: Zdravilo Revlimid je zdravilo proti raku.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far require follow-up with more mature data to allow the Committee to reach a clear conclusion on the benefit-risk balance.
Slovenian: V svojem uradnem dopisu je družba navedla, da odločitev o umiku vloge temelji na mnenju odbora CHMP, da bi bilo treba do tedaj predložene podatke dopolniti s spremljevalnimi študijami, ki bi zagotovile zanesljivejše podatke, na podlagi katerih bi lahko odbor sprejel jasen sklep o razmerju med koristmi in tveganji.
English: The company informed the CHMP that clinical trials or compassionate use programmes will not be interrupted and patients will continue to be carefully monitored with respect to overall survival and development of new cancers.
Slovenian: Družba je CHMP obvestila, da klinična preskušanja ali programi sočutne uporabe zdravila ne bodo moteni in da bodo pri bolnikih nadalje pozorno spremljali skupni čas preživetja in pojav novih rakavih obolenj.
English: The active substance in Revlimid, lenalidomide, is an immunomodulating agent.
Slovenian: Zdravilna učinkovina v zdravilu Revlimid, lenalidomid, je imunomodulator.
English: There are no consequences on the use of Revlimid in its authorised indication, as Revlimid has a positive benefit-risk balance when used in patients with multiple myeloma who have already had one or more other types of treatment before2.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Revlimid za odobrene indikacije, saj ima zdravilo Revlimid pozitivno razmerje med koristmi in tveganji, če se uporablja pri bolnikih z multiplim mielomom, ki so že prejeli eno ali več drugih vrst zdravljenja2.
English: In newly diagnosed multiple myeloma, Revlimid was expected to work in the same way as it does in its existing indication.
Slovenian: Pri na novo diagnosticiranem multiplem mielomu naj bi zdravilo Revlimid delovalo enako kot pri obstoječi indikaciji.
English: Revlimid was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 12 December 2003 for multiple myeloma.
Slovenian: Zdravilo Revlimid je bilo dne 12. decembra 2003 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za multipli mielom.
English: In the first study, patients were given melphalan and prednisone together with either Revlimid or placebo (a dummy treatment) during an initial phase, followed by a maintenance phase where patients received Revlimid or placebo.
Slovenian: V prvi študiji so bolniki v začetni fazi prejemali melfalan in prednizon v kombinaciji z zdravilom Revlimid ali s placebom (zdravilom brez zdravilne učinkovine), čemur je sledila vzdrževalna faza, v okviru katere so bolniki prejemali zdravilo Revlimid ali placebo.
English: Revlimid was also expected to be used for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with Revlimid, melphalan, and prednisone (other medicines to treat multiple myeloma), or following autologous stem cell transplant (a transplant of the patient's own blood-producing cells).
Slovenian: Zdravilo Revlimid naj bi se uporabljalo tudi za vzdrževalno zdravljenje bolnikov z na novo diagnosticiranim multiplim mielomom, pri katerih po začetnem zdravljenju z zdravili Revlimid, melfalan in prednizon (drugimi zdravili za zdravljenje multiplega mieloma) ali po avtologni presaditvi matičnih celic (presaditev bolnikovih lastnih krvotvornih celic) ni prišlo do napredovanja bolezni.
English: Furthermore, since Revlimid was associated with an increased risk of developing new cancers, the CHMP could not rule out that the lack of a longer survival could be due to death caused by new cancers.
Slovenian: Ker je bilo jemanje zdravila Revlimid povezano s povečanim tveganjem za pojav novih rakavih obolenj, CHMP ni mogel izključiti možnosti, da je lahko odsotnost daljšega preživetja posledica smrti zaradi pojava novih rakavih obolenj.
English: It is used in combination with dexamethasone (an antiinflammatory medicine) to treat adults with multiple myeloma whose disease has been treated at least once in the past (second-line treatment).
Slovenian: Uporablja se v kombinaciji z deksametazonom (protivnetnim zdravilom) za zdravljenje odraslih z multiplim mielomom, ki so se v preteklosti zaradi te bolezni zdravili vsaj enkrat (zdravljenje druge izbire).
English: The second study compared Revlimid with placebo in patients who had received an autologous stem cell transplant.
Slovenian: V drugi študiji so zdravilo Revlimid primerjali s placebom pri bolnikih, ki so prejeli avtologno presaditev matičnih celic.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Revlimid could not have been approved to treat newly diagnosed multiple myeloma patients.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Revlimid ni mogoče odobriti za zdravljenje bolnikov z na novo diagnosticiranim multiplim mielomom.
English: What is Revlimid?
Slovenian: Kaj je zdravilo Revlimid?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Revlimid in newly diagnosed multiple myeloma patients did not outweigh its risks.
Slovenian: CHMP je zato v času umika menil, da koristi zdravila Revlimid pri bolnikih z na novo diagnosticiranim multiplim mielomom ne odtehtajo z njim povezanih tveganj.
English: The main measure of effectiveness was how long the patients survived without their disease getting worse.
Slovenian: Glavno merilo učinkovitosti je bil čas, potreben do poslabšanja bolezni.
English: What is happening with Revlimid for the treatment of multiple myeloma?
Slovenian: Kakšne so posledice za zdravilo Revlimid, indicirano za zdravljenje multiplega mieloma?
English: This study looked at how long patients survived after the transplant without their disease getting worse.
Slovenian: V študiji so merili čas preživetja po presaditvi, potreben do poslabšanja bolezni.
English: The Committee was concerned that, while there was a clear benefit in terms of delaying the progression of the disease in newly diagnosed multiple myeloma patients, this did not lead to a meaningful improvement of symptoms and longer survival.
Slovenian: Čeprav je bilo zdravilo učinkovito pri odložitvi napredovanja bolezni pri bolnikih z na novo diagnosticiranim multiplim mielomom, je bil odbor zaskrbljen zaradi dejstva, da to ni vodilo do pomembnega izboljšanja simptomov in daljšega časa preživetja.
English: What was Revlimid expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Revlimid uporabljalo?
English: How is Revlimid expected to work?
Slovenian: Kako naj bi zdravilo Revlimid delovalo?
English: • 10 seconds has passed,
Slovenian: • minilo je 10 sekund,
English: These must NEVER be re-used.
Slovenian: NIKOLI jih ne smete ponovno uporabiti.
English: Read the instructions carefully and follow them step by step.
Slovenian: Navodilo natančno preberite in ga upoštevajte korak za korakom.
English: However, some may be serious and require urgent medical treatment.
Slovenian: Nekateri pa so lahko resni in zahtevajo takojšnje zdravljenje.
English: They will also tell you the prescribed amount (volume).
Slovenian: Poleg tega vam bo povedal, kolikšna je predpisana količina (volumen).
English: Before you start
Slovenian: Pred začetkom
English: • impotence.
Slovenian: • impotenca.
English: Make sure you know the prescribed amount .
Slovenian: Prepričajte se, da poznate predpisano količino.
English: • A 2nd “CLICK” is heard,
Slovenian: • slišite drugi »KLIK«,
English: Fewer than half of at-risk subjects had an event.
Slovenian: Manj kot polovica rizičnih preiskovancev je imela dogodek.
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Slovenian: Posebna pozornost glede tveganja okužb je potrebna pri zdravljenju starejših oseb.
English: You will set the volume to the prescribed dose in a later step.
Slovenian: Količino boste nastavili na predpisani odmerek v poznejšem koraku.
English: • DO NOT inject through clothes.
Slovenian: • NE injicirajte skozi oblačila.
English: 61352 Bad Homburg v. d. Höhe Germany
Slovenian: 61352 Bad Homburg v. d. Höhe Nemčija
English: • Orange Indicator has stopped and completely blocked the Viewing Window.
Slovenian: • oranžni kazalnik se je ustavil in povsem zapolnil kontrolno okence.
English: ASDAS Inactive Disease hs-CRPd,f,g
Slovenian: ASDAS neaktivna bolezen hs-CRPd, f, g
English: Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.
Slovenian: Večina primerov tuberkuloze se je pojavila v prvih osmih mesecih po začetku zdravljenja, mogoče je, da gre za ponoven izbruh latentne bolezni.
English: ASASa Partial Remission
Slovenian: ASASa delna remisija
English: Maintenance Dose Starting at week 4
Slovenian: Vzdrževalni odmerek z začetkom v 4. tednu
English: A few drops of liquid may come out of the needle, this is normal.
Slovenian: Iz igle lahko izteče nekaj kapljic tekočine, kar je normalno.
English: Detailed instructions on how to inject Hulio are provided in Section 7 - Instructions for use.
Slovenian: Podrobna navodila o tem, kako injicirati zdravilo Hulio, so navedena v poglavju 7 - Navodilo za uporabo.
English: • DO NOT touch the Orange Activator with your fingers (this is where the needle comes out).
Slovenian: • NE dotikajte se oranžnega aktivatorja s svojimi prsti (tukaj izskoči igla).
English: This 1st “CLICK” signals the start of the injection.
Slovenian: Prvi »KLIK« označuje začetek injiciranja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 17. september 2018
English: Hidradenitis suppurativa (sometimes called ‘acne inversa') is a long-term and often painful inflammatory skin disease.
Slovenian: Hidradenitis suppurativa (včasih imenovan tudi acne inversa) je dolgotrajna in pogosto boleča vnetna bolezen kože.
English: If you see air bubbles in the solution again, you may repeat this step up to 3 times.
Slovenian: Če so v raztopini ponovno zračni mehurčki, lahko ta korak ponovite do trikrat.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba zelo natančno pretehtati korist in tveganje zdravljenja.
English: ≥30% Reduction in Skin Painb
Slovenian: ≥ 30 % zmanjšanje bolečine na kožib
English: • Stevens-Johnson syndrome;
Slovenian: • Stevens-Johnsonov sindrom;
English: Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Slovenian: Bolniki z dedno intoleranco za fruktozo (HFI) ne smejo jemati/dobiti tega zdravila.
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>.
English: Step 11 - Check and set prescribed dose
Slovenian: 11. korak - Preverite in pripravite predpisani odmerek.
English: Hulio may be available in other presentations depending on the individual treatment needs.
Slovenian: Zdravilo Hulio je lahko na voljo v drugih oblikah, odvisno od individualnih potreb zdravljenja.
English: • slow healing of wounds.
Slovenian: • počasno celjenje ran.
English: • In some patients the body may fail to produce enough of the blood cells that fight infections or help you to stop bleeding.
Slovenian: • Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
English: • excessive night urination;
Slovenian: • čezmerno uriniranje ponoči;
English: Week 24 BASDAIb 50
Slovenian: 24. teden BASDAIb 50
English: Table 19: Maintenance regimen
Slovenian: Preglednica 19: Vzdrževalni režim
English: Monoclonal antibodies are proteins that attach to specific target in the body.
Slovenian: Monoklonska protitelesa so beljakovine, ki se vežejo na specifične tarče v telesu.
English: Table 25: Maintenance regimen
Slovenian: Preglednica 25: Vzdrževalni režim
English: In rare cases, these infections may be lifethreatening.
Slovenian: V redkih primerih so lahko te okužbe življenjsko ogrožujoče.
English: • pain in bone and muscles.
Slovenian: • bolečine v kosteh in mišicah.
English: • Wait for the skin to dry on its own, do not blow it dry.
Slovenian: • Počakajte, da se koža sama posuši in je ne sušite.
English: Scarring may also occur in affected areas.
Slovenian: Na prizadetih območjih se lahko pojavijo tudi brazgotine.
English: Hulio can also be given alone.
Slovenian: Zdravilo Hulio se lahko daje tudi samo.
English: Each pack is for single use only
Slovenian: Vsako pakiranje je namenjeno samo za enkratno uporabo.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Slovenian: V koloni Organski sistem (OS) se pojavi zvezdica (*), če je nadaljnje informacije mogoče najti drugod v poglavjih 4.3, 4.4 in 4.8.
English: If there is a second box in the Hulio pack for a future injection, place it back in the refrigerator immediately.
Slovenian: Če pakiranje zdravila Hulio vsebuje še eno škatlo za naslednje injiciranje, jo nemudoma shranite nazaj v hladilnik.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Hulio.
Slovenian: Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Hulio.
English: • If you are over 65 years you may be more susceptible to infections while taking Hulio.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Hulio.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Slovenian: Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 % glede na materin serum.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received Hulio during pregnancy compared with mothers with the same disease who did not receive Hulio.
Slovenian: Glede na študijo pri nosečnicah ni bilo povečanega tveganja za okvare pri rojstvu, če je mati prejemala zdravilo Hulio med nosečnostjo v primerjavi z materami z isto boleznijo, ki niso prejemale zdravila Hulio.
English: • difficulty sleeping;
Slovenian: • težave s spanjem;
English: Percent Change in Total Fingernail NAPSI (%)
Slovenian: Odstotek spremembe v celotnem indeksu NAPSI (%) za nohte
English: Hulio in combination with methotrexate, is indicated for:
Slovenian: Zdravilo Hulio je v kombinaciji z metotreksatom indicirano za:
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Slovenian: a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
English: • Throw away all other used items and empty packaging into your regular household waste.
Slovenian: • Zavrzite vse ostale uporabljene enote in prazno ovojnino zdravila v običajen koš za odpadke.
English: If you don't know this, STOP HERE and ask your child's doctor.
Slovenian: Če tega ne veste, se TUKAJ USTAVITE in vprašajte otrokovega zdravnika.
English: Prior to launch of Hulio in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred začetkom trženja zdravila Hulio se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načinom razdeljevanja in drugimi vidiki programa.
English: Multipack containing 2 (2 packs of 1) vials.
Slovenian: Večkratno pakiranje vsebuje 2 (2 pakiranji po 1) viali.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Slovenian: pogosti poslabšanje ali nov pojav psoriaze (vključno s palmoplantarno pustularno psoriazo)1),
English: The educational program consists of a Patient Reminder Card.
Slovenian: Izobraževalni program vsebuje opozorilno kartico za bolnike.
English: If needed, cover the injection site with a plaster.
Slovenian: Po potrebi injekcijsko mesto prekrijte z obližem.
English: Hulio is supplied as packs containing 1 or 2 boxes.
Slovenian: Zdravilo Hulio je na voljo v pakiranju, ki vsebuje 1 ali 2 škatli.
English: hydrochloric acid and water for injections.
Slovenian: klorovodikova kislina in voda za injekcije.
English: A large number (approximately 2,100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1,500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Veliko število (približno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo živorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
English: Wash your hands thoroughly with soap and water.
Slovenian: Dobro si umijte roki z milom in vodo.
English: Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Slovenian: Bolnike s kliničnim odzivom (znižanje CDAI ≥ 70) v 4. tednu so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva v 4. tednu.
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Slovenian: Bolniki, ki so dosegli PASI 75 in PGA čisto ali minimalno, so bili iz zdravljenja odpuščeni do 36 tednov in spremljani glede izgube nadzora nad boleznijo (tj. poslabšanje PGA za najmanj 2 stopnji).
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Slovenian: Poročila so vključevala primere pljučne in zunajpljučne (tj. Diseminirane) tuberkuloze.
English: Hulio is intended for the treatment of the following inflammatory diseases:
Slovenian: Zdravilo Hulio je namenjeno za zdravljenje naslednjih vnetnih bolezni:
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Slovenian: V primeru, ko je potreben hitrejši odziv na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov lahko povečano ob uporabi večjega začetnega odmerka, se lahko uporabi naslednji odmerek:
English: Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4)
Slovenian: Ocena erozij 3,7 (2,7-4,7) 1,7 (1,0-2,4)
English: If retreatment with Hulio is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom Hulio, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljenja.
English: Continue holding the body of the pen down against the injection site until one, or all, of the following occur:
Slovenian: Injekcijski peresnik še naprej držite navzdol proti injekcijskemu mestu, dokler se ne zgodi eno ali vse od naštetega:
English: By attaching to TNFα, Hulio decreases the process of inflammation in these diseases.
Slovenian: Z vezavo na TNFα zdravilo Hulio zmanjša vnetni proces pri teh boleznih.
English: Repeat this step to draw the solution back into the syringe again, pulling the plunger rod SLOWLY.
Slovenian: Ponovite ta korak, da raztopino ponovno povlečete v brizgo, in sicer tako, da nosilec bata POČASI potegnete ven.
English: Contents of the pack and other information Instructions for use
Slovenian: Vsebina pakiranja in dodatne informacije Navodilo za uporabo
English: It is also normal to see air bubble(s).
Slovenian: Normalno je tudi, da so vidni zračni mehurčki.
English: phase
Slovenian: Faza
English: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Slovenian: Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ25.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Slovenian: TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem, njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
English: Components inside the pen may be broken.
Slovenian: Sestavni deli v injekcijskem peresniku so morda zlomljeni.
English: Treatment with Hulio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Hulio se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Slovenian: Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje na več kot 1 od 6 meril za > 30 %.
English: • DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
Slovenian: • NE nameščajte pokrovčka nazaj na iglo in se ne dotikajte igle s svojimi prsti ter ne dovolite, da se igla česar koli dotakne.
English: Time to Treatment Failure At or After week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab Time to Treatment Failure At or After week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab
Slovenian: Čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I Primarna analiza (ITT) placebo adalimumab Čas do neuspeha zdravljenja v ali po 2. tednu v študiji UV II Primarna analiza (ITT) placebo adalimumab