A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

NCT02046603 | Completed Phase 3 Results

• 2 other identifiers: ML286412013-000054-22
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 38

Brief Summary

This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (15)

• Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2

  DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR greater than or equal to (≥) 2.6 to less than or equal to (≤) 3.2 implied low disease activity, greater than (\>) 3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and less than (\<) 2.6 implied clinical remission.

  Baseline, Week 2

• Change From Baseline in DAS28-ESR at Week 4

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 4

• Change From Baseline in DAS28-ESR at Week 8

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 8

• Change From Baseline in DAS28-ESR at Week 12

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 12

• Change From Baseline in DAS28-ESR at Week 16

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 16

• Change From Baseline in DAS28-ESR at Week 20

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 20

• Change From Baseline in DAS28-ESR at Week 24

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 24

• Change From Baseline in DAS28-ESR at Week 28

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 28

• Change From Baseline in DAS28-ESR at Week 32

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 32

• Change From Baseline in DAS28-ESR at Week 36

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 36

• Change From Baseline in DAS28-ESR at Week 40

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 40

• Change From Baseline in DAS28-ESR at Week 44

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 44

• Change From Baseline in DAS28-ESR at Week 48

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 48

• Change From Baseline in DAS28-ESR at Week 52

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, Week 52

• Change From Baseline in DAS28-ESR at Early Withdrawal

  DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.

  Baseline, early withdrawal (up to Week 52)

Secondary Outcomes (22)

• Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)

• Number of Participants Achieving an ACR50 Response

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)

• Number of Participants Achieving an ACR70 Response

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)

• Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)

• Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)

Study Arms (2)

Tocilizumab Monotherapy

EXPERIMENTAL

Participants will receive a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks.

Drug: Tocilizumab

Tocilizumab in Combination With Methotrexate or Other DMARDs

EXPERIMENTAL

Participants will receive a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.

Drug: Tocilizumab; Drug: DMARDs; Drug: Oral Corticosteroids; Drug: Methotrexate

Interventions

Tocilizumab DRUG

Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.

Also known as: RoActemra, Actemra

Tocilizumab Monotherapy; Tocilizumab in Combination With Methotrexate or Other DMARDs

DMARDs DRUG

Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.

Tocilizumab in Combination With Methotrexate or Other DMARDs

Oral Corticosteroids DRUG

Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.

Tocilizumab in Combination With Methotrexate or Other DMARDs

Methotrexate DRUG

Methotrexate per investigator's discretion.

Tocilizumab in Combination With Methotrexate or Other DMARDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria
• Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines
• Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to \[≥\] 4 weeks prior to baseline
• Permitted non-biologic DMARDs are allowed if on stable dose for at least 4 weeks prior to baseline
• Receiving treatment on an outpatient basis, not including tocilizumab
• Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol during the study and for at least 3 months following the last dose of tocilizumab

You may not qualify if:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
• Rheumatic autoimmune disease other than RA
• Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
• Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
• Prior history of or current inflammatory joint disease other than RA
• Exposure to tocilizumab either intravenous or SC at any time prior to baseline
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
• Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
• Known active current or history of recurrent infections
• Major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
• Active tuberculosis (TB) requiring treatment within the previous 3 years
• Positive for hepatitis B or hepatitis C virus infection
• Primary or secondary immunodeficiency (history of or currently active)
• Pregnant or lactating women

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (38)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Christchurch Hospital; Rheumatology

Bournemouth, BH23 2JX, United Kingdom

Location

Royal Sussex County Hospital; Clinical Investigation Research Unit

Brighton, BN2 5BE, United Kingdom

Location

Queens Hospital

Burton-on-Trent, DE13 0RB, United Kingdom

Location

West Suffolk Hospital

Bury Saint Edmonds, IP33 2QZ, United Kingdom

Location

Addenbrooke'S Hospital; Rheumatology Research Unit

Cambridge, CB2 2QQ, United Kingdom

Location

Cannock Chase Hospital; Rheumatology

Cannock, WS11 5XY, United Kingdom

Location

University Hospital of Wales; Dept of Rhematology

Cardiff, CF14 4XW, United Kingdom

Location

Broomfield Hospital

Chelmsford, CM1 7ET, United Kingdom

Location

Countess of Chester Hospital; Dept of Rheumatology

Chester, CH2 1UL, United Kingdom

Location

Dewsbury & District Hospital; Dept of Rheumatology

Dewsbury, WF13 4HS, United Kingdom

Location

Russells Hall Hospital; Rheumatology Department

Dudley, DY1 2HQ, United Kingdom

Location

Ninewells Hospital

Dundee, DD12 9SY, United Kingdom

Location

Eastbourne District General Hospital; Dept of Rheumatology

Eastbourne, BN21 2UD, United Kingdom

Location

Western General Hospital; Pharmacy Department

Edinburgh, EH4 2XU, United Kingdom

Location

Gartnavel General Hospital; Rheumatology

Glasgow, G12 0YN, United Kingdom

Location

Diana Princess of Wales Hosp.

Grimsby, DN33 2BA, United Kingdom

Location

Princess Alexandra Hospital

Harlow, CM20 1QX, United Kingdom

Location

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location

Hemel Hempstead General Hospital; Rheumatology Dept

Hemel Hempstead, HP2 4AD, United Kingdom

Location

Hull Royal Infirmary; Rheumatology Department

Hull, HU3 3JZ, United Kingdom

Location

Llandudno General Hospital

Llandudno, LL30 1LB, United Kingdom

Location

Whipps Cross Hospital; Rheumatology Dept

London, E11 1NR, United Kingdom

Location

Royal Free Hospital; Department of Rheumatology

London, NW3 2QG, United Kingdom

Location

Maidstone Hospital; Dept of Rheumatology

Maidstone, ME16 9QQ, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9QZ, United Kingdom

Location

Freeman Hospital; Dept of Rheumatology

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE29 8NH, United Kingdom

Location

Norfolk & Norwich Hospital; Rheumatology

Norwich, NR4 7UY, United Kingdom

Location

Integrated Care Centre

Oldham, OL1 1NL, United Kingdom

Location

Solihull Hospital

Solihull, B91 2JL, United Kingdom

Location

Haywood Hospital; Staffordshire Rheumatology Centre

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Great Western Hospital; Dept of Rheumatology

Swindon, SN3 6BB, United Kingdom

Location

Torbay Hospital; Dept of Rhematology

Torquay, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital; Rhuematololgy Dept

Truro, TR1 3LJ, United Kingdom

Location

Warrington Hospital

Warrington, WA5 1QG, United Kingdom

Location

Wrightington Hospital; Rheumatology

Wigan, WN6 9EW, United Kingdom

Location

Wishaw General Hospital

Wishaw, ML2 0DP, United Kingdom

Location

Related Publications (3)

• Isaacs JD, Salih A, Sheeran T, Patel YI, Douglas K, McKay ND, Naisbett-Groet B, Choy E. Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study. Rheumatol Adv Pract. 2019 Apr 19;3(1):rkz010. doi: 10.1093/rap/rkz010. eCollection 2019.

  PMID: 31431998 DERIVED

• Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

  PMID: 30649524 DERIVED

• Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.

  PMID: 29244149 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Antirheumatic Agents; Adrenal Cortex Hormones; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: March 4, 2014
• Primary Completion: August 4, 2016
• Study Completion: August 4, 2016
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-05

Locations

GB (38)