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AzTrials

Rheumatoid ArthritisPhase 2NCT01463059

Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Phase 2 study testing Olokizumab 60 mg, Olokizumab 120 mg and Olokizumab 240 mg in people with Rheumatoid Arthritis, run by UCB Japan Co. Ltd. at 39 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Olokizumab 60 mg, Olokizumab 120 mg and Olokizumab 240 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
39 sitesin 3 countries
Study dates
Oct 2011to Feb 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
  • Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR >28mm/hour
  • Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
  • Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
  • Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Who cannot join

  • Have a diagnosis of any other inflammatory arthritis
  • Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
  • Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
  • Subjects with known concurrent acute or chronic viral hepatitis B or C infection
  • Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
  • Subjects with known history of or current clinically active infection
Show all 10Show fewer
  • Subjects at high risk of infection
  • Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
  • Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
  • Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

Japan23 sites

  • 102

    Chiba

  • 114

    Fukuoka

  • 115

    Fukuoka

  • 113

    Hiroshima

  • 120

    Kakogawa

  • 118

    Kumamoto

  • 116

    Kurume

  • 121

    Matsuyama

  • 122

    Matsuyama

  • 107

    Nagaoka

  • 110

    Nagoya

  • 103

    Narita

  • 119

    Ōita

  • 112

    Okayama

  • 100

    Sapporo

  • 117

    Sasebo

  • 124

    Tokorozawa

  • 123

    Tokyo

  • 101

    Tomakomai

  • 108

    Tonami

  • 111

    Tsu

  • 105

    Yokohama

  • 104

    Yotukaido

Other trials in Japan

Taiwan11 sites

  • 303

    Changhua

  • 304

    Dalin-Town

  • 305

    Hualien City

  • 300

    Kaohsiung City

  • 301

    Taichung

  • 306

    Taichung

  • 307

    Taichung

  • 302

    Taipei

  • 308

    Taipei

  • 309

    Taipei

  • 310

    Taipei

Other trials in Taiwan

South Korea5 sites

  • 200

    Daejeon

  • 201

    Junggu

  • 202

    Seongdong-gu

  • 203

    Seoul

  • 204

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.

Being tested
Placebo, Olokizumab 60 mg, Olokizumab 120 mg, Olokizumab 240 mg
Keywords
Rheumatoid Arthritis, Monoclonal Antibody, Interleukin-6, Olokizumab, CDP6038
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Placebo solution for injection, administered as subcutaneous injections

  • Olokizumab 60 mgBiological

    Also called CDP6038

    Olokizumab 60 mg solution for injection, administered as subcutaneous injections

  • Olokizumab 120 mgBiological

    Also called CDP6038

    Olokizumab 120 mg solution for injection, administered as subcutaneous injections

  • Olokizumab 240 mgBiological

    Also called CDP6038

    Olokizumab 240 mg solution for injection, administered as subcutaneous injections

Study groups in NCT01463059
Study groupRoleWhat they receive
Placebo every 2 weeksPlacebo comparatorInjections administered at week 0, 2, 4, 6, 8 and 10
Receives: Biological: Placebo
Olokizumab 60 mg every 2 weeksExperimentalOlokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Receives: Biological: Olokizumab 60 mg
Olokizumab 60 mg every 4 weeksExperimentalOlokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
Receives: Biological: Placebo; Biological: Olokizumab 60 mg
Olokizumab 120 mg every 2 weeksExperimentalOlokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Receives: Biological: Olokizumab 120 mg
Olokizumab 120 mg every 4 weeksExperimentalOlokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Receives: Biological: Placebo; Biological: Olokizumab 120 mg
Olokizumab 240 mg very 4 weeksExperimentalOlokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Receives: Biological: Placebo; Biological: Olokizumab 240 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12

    Measured: From Week 0 (Baseline) to Week 12

Secondary outcomes (3)

  1. Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12

    Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

    Measured: From Week 0 (Baseline) to Week 12

  2. Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12

    Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

    Measured: From Week 0 (Baseline) to Week 12

  3. Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12

    Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

    Measured: From Week 0 (Baseline) to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463059
Sponsor's protocol ID
RA0083
Status last verified
Mar 2013
First submitted
27 Oct 2011
Last updated
25 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Takeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, Park W, Shiozawa K, Tsukano M, Wei JC, Shao J, Togo O, Mashimo H. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15-23. doi: 10.3109/14397595.2015.1074648. Epub 2015 Sep 10.

    PubMed 26358841

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olokizumab 60 mg, Olokizumab 120 mg and Olokizumab 240 mg in people with Rheumatoid Arthritis, run by UCB Japan Co. Ltd. at 39 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Japan, Taiwan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12 (time frame: From Week 0 (Baseline) to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01463059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.

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