Rheumatoid ArthritisPhase 2NCT01533714
The Long-term Safety and Efficacy of CDP6038 (Olokizumab) With Active Rheumatoid Arthritis
A Phase 2 study testing CDP6038 (olokizumab) in people with Rheumatoid Arthritis, run by UCB BIOSCIENCES, Inc. at 32 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 [NCT01463059]. 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?
- CDP6038 (olokizumab)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 26 Jan 2012to 29 Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completed the RA0083 [NCT01463059] study (Week 12 Visit)
- Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059], and plan to maintain this same dose and route of administration for at least 12 weeks
- 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 an ongoing SAE from the RA0083 [NCT01463059] study
- Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
- Have evidence of active or latent tuberculosis (TB)
- Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
- Subject has planned surgery during the first 12 weeks of the study
- Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 [NCT01463059]
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
Japan21 sites
102
Chiba
114
Fukuoka
115
Fukuoka
113
Hiroshima
120
Kakogawa
118
Kumamoto
116
Kurume
122
Matsuyama
107
Nagaoka
110
Nagoya
103
Narita
119
Ōita
112
Okayama
100
Sapporo
117
Sasebo
123
Tokyo
101
Tomakomai
108
Tonami
111
Tsu
105
Yokohama
104
Yotukaido
Taiwan6 sites
301
Taichung
306
Taichung
307
Taichung
302
Taipei
308
Taipei
309
Taipei
South Korea5 sites
200
Daejeon
201
Junggu
202
Seongdong-Gu
203
Seoul
204
Seoul
About this study
Official title: Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083
The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 [NCT01463059].
Read the detailed description
Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CDP6038 (olokizumab)
- 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.
CDP6038 (olokizumab)Biological
Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
| Study group | Role | What they receive |
|---|---|---|
| CDP6038 (olokizumab) | Experimental | CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083). Receives: Biological: CDP6038 (olokizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
Measured: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Secondary outcomes (30)
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (>) 5.1 correspond with active disease, scores less than (<) 3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Measured: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Measured: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Measured: Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Measured: Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.
Measured: Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.
Measured: Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Measured: Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Measured: Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Measured: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Measured: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Measured: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Measured: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study start26 Jan 2012
- Primary completion27 Nov 2013
- Study completion29 Nov 2013
Why it stopped: Decision to out-license the compound for further development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R-Pharm
- Responsible party
- Sponsor
- Investigators
- Tsutomu Takeuchi, Professor, Principal investigator, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533714
- Sponsor's protocol ID
- RA0089
- Status last verified
- May 2022
- First submitted
- 10 Feb 2012
- Last updated
- 20 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083
- ClinicalTrials.gov ID
- NCT01533714
- Acronym / sponsor ID
- RA0089
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Monoclonal antibody, Interleukin-6, Olokizumab, CDP6038
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to out-license the compound for further development
- Enrolment
- 103 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- R-Pharm
- Study start
- 26 Jan 2012 (actual)
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 29 Nov 2013 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 [NCT01463059].
Detailed description
Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
| Arm | Type | Receives |
|---|---|---|
| CDP6038 (olokizumab) | Experimental | Biological: CDP6038 (olokizumab)CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed the RA0083 [NCT01463059] study (Week 12 Visit)
- Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059], and plan to maintain this same dose and route of administration for at least 12 weeks
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Key exclusion criteria (6 listed)
- Have an ongoing SAE from the RA0083 [NCT01463059] study
- Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
- Have evidence of active or latent tuberculosis (TB)
- Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
- Subject has planned surgery during the first 12 weeks of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDP6038 (olokizumab)Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection | Biological | CDP6038 (olokizumab) |
Primary outcome
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
30 secondary outcomes
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
Time frame: Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
Time frame: Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
Time frame: Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
Time frame: Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
Time frame: Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
Time frame: Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
Time frame: Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
Time frame: Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Time frame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
Time frame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsutomu Takeuchi, Professor principal investigator
Keio University
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDP6038 (olokizumab) in people with Rheumatoid Arthritis, run by UCB BIOSCIENCES, Inc. at 32 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. 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?
Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) (time frame: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022.