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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

1. august 2012 oppdatert av: Abbott

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

Studietype

Intervensjonell

Registrering (Faktiske)

334

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • Anjo, Japan
        • Site Reference ID/Investigator# 46861
      • Aomori, Japan
        • Site Reference ID/Investigator# 46919
      • Chiba, Japan
        • Site Reference ID/Investigator# 46805
      • Chiba, Japan
        • Site Reference ID/Investigator# 46806
      • Chiba, Japan
        • Site Reference ID/Investigator# 46880
      • Chiba, Japan
        • Site Reference ID/Investigator# 46881
      • Fuchu, Japan
        • Site Reference ID/Investigator# 46890
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46902
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46903
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 46904
      • Gifu, Japan
        • Site Reference ID/Investigator# 46856
      • Gunma, Japan
        • Site Reference ID/Investigator# 46944
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 46893
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 46894
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 12161
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 46916
      • Hokkaido, Japan
        • Site Reference ID/Investigator# 46918
      • Hyogo, Japan
        • Site Reference ID/Investigator# 46865
      • Hyogo, Japan
        • Site Reference ID/Investigator# 46871
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 46801
      • Ibaraki, Japan
        • Site Reference ID/Investigator# 46925
      • Iwate, Japan
        • Site Reference ID/Investigator# 46800
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 46873
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 46874
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46845
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46899
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 46901
      • Kanazawa, Japan
        • Site Reference ID/Investigator# 46851
      • Kanazawa, Japan
        • Site Reference ID/Investigator# 46852
      • Kawagoe, Japan
        • Site Reference ID/Investigator# 46802
      • Kawasaki, Japan
        • Site Reference ID/Investigator# 46900
      • Kirishima, Japan
        • Site Reference ID/Investigator# 46875
      • Kitakyushu, Japan
        • Site Reference ID/Investigator# 46870
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 46872
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 46912
      • Kyoto, Japan
        • Site Reference ID/Investigator# 46864
      • Maebashi, Japan
        • Site Reference ID/Investigator# 46943
      • Matsuyama, Japan
        • Site Reference ID/Investigator# 46898
      • Miyazaki, Japan
        • Site Reference ID/Investigator# 46915
      • Nagano, Japan
        • Site Reference ID/Investigator# 46853
      • Nagano, Japan
        • Site Reference ID/Investigator# 46855
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46909
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46910
      • Nagasaki, Japan
        • Site Reference ID/Investigator# 46911
      • Nagoya, Japan
        • Site Reference ID/Investigator# 46858
      • Nagoya, Japan
        • Site Reference ID/Investigator# 46860
      • Nara, Japan
        • Site Reference ID/Investigator# 46877
      • Nara, Japan
        • Site Reference ID/Investigator# 46885
      • Niigata, Japan
        • Site Reference ID/Investigator# 46848
      • Niigata, Japan
        • Site Reference ID/Investigator# 46906
      • Oita, Japan
        • Site Reference ID/Investigator# 46914
      • Okayama, Japan
        • Site Reference ID/Investigator# 46869
      • Okayama, Japan
        • Site Reference ID/Investigator# 46886
      • Okayama, Japan
        • Site Reference ID/Investigator# 46887
      • Okayama, Japan
        • Site Reference ID/Investigator# 46892
      • Okinawa, Japan
        • Site Reference ID/Investigator# 46876
      • Osaka, Japan
        • Site Reference ID/Investigator# 46946
      • Osaka, Japan
        • Site Reference ID/Investigator# 46947
      • Rifu, Japan
        • Site Reference ID/Investigator# 46842
      • Sagamihara, Japan
        • Site Reference ID/Investigator# 46846
      • Saitama, Japan
        • Site Reference ID/Investigator# 46803
      • Saitama, Japan
        • Site Reference ID/Investigator# 46804
      • Saitama, Japan
        • Site Reference ID/Investigator# 46878
      • Saitama, Japan
        • Site Reference ID/Investigator# 46879
      • Sapporo, Japan
        • Site Reference ID/Investigator# 46917
      • Shimotsuke, Japan
        • Site Reference ID/Investigator# 46942
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46854
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46857
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 46859
      • Takamatsu, Japan
        • Site Reference ID/Investigator# 46895
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46843
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46844
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46850
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46882
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46883
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46884
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46888
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46889
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46891
      • Tokyo, Japan
        • Site Reference ID/Investigator# 46896
      • Toyama, Japan
        • Site Reference ID/Investigator# 46849
      • Toyama, Japan
        • Site Reference ID/Investigator# 46907
      • Toyoake, Japan
        • Site Reference ID/Investigator# 46862
      • Toyohashi, Japan
        • Site Reference ID/Investigator# 46866
      • Tsu, Japan
        • Site Reference ID/Investigator# 46863
      • Tsukuba, Japan
        • Site Reference ID/Investigator# 46926
      • Yokohama, Japan
        • Site Reference ID/Investigator# 46897
      • Yokohama, Japan
        • Site Reference ID/Investigator# 46905

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  • Rheumatoid arthritis based on the American College of Rheumatology criteria
  • Methotrexate or leflunomide naïve
  • Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

  • History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
  • Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
  • Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: DB Placebo
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Legemiddel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andre navn:
  • Placebo
Eksperimentell: DB adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Biologisk: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andre navn:
  • ABT-D2E7, adalimumab, Humira
Eksperimentell: DB Adalimumab/OL Adalimumab
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Biologisk: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andre navn:
  • ABT-D2E7, adalimumab, Humira
Biologisk: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira
Eksperimentell: DB Placebo/OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Legemiddel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andre navn:
  • Placebo
Biologisk: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira
Eksperimentell: DB Adalimumab/RE OL Adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Biologisk: Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Andre navn:
  • ABT-D2E7, adalimumab, Humira
Biologisk: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira
Biologisk: Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira
Eksperimentell: DB Placebo/RE OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Legemiddel: Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Andre navn:
  • Placebo
Biologisk: Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira
Biologisk: Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Andre navn:
  • adalimumab
  • ABT-D2E7
  • Humira

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Tidsramme: Baseline, Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 26

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Tidsramme: Week 26
Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Tidsramme: Week 26
Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Tidsramme: Week 26
Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Tidsramme: Baseline, Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 26
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Tidsramme: Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 26
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Tidsramme: Through Week 26
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.
Through Week 26
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Tidsramme: Baseline, Week 52
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 52
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Tidsramme: Week 52
Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Tidsramme: Week 52
Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Tidsramme: Week 52
Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Tidsramme: Baseline, Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 52
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Tidsramme: Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 52
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Tidsramme: Through Week 52
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.
Through Week 52

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott

Samarbeidspartnere

Eisai Co., Ltd.

Etterforskere

  • Studieleder: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2009

Primær fullføring (Faktiske)

1. mars 2011

Studiet fullført (Faktiske)

1. august 2011

Datoer for studieregistrering

Først innsendt

26. mars 2009

Først innsendt som oppfylte QC-kriteriene

26. mars 2009

Først lagt ut (Anslag)

27. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. august 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2012

Sist bekreftet

1. august 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M06-859

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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