Rheumatoid ArthritisPhase 2NCT01242488

Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

A Phase 2 study testing CDP6038 and Tocilizumab (Actemra or RoActemra) in people with Rheumatoid Arthritis, run by UCB Pharma at 82 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: CDP6038 and Tocilizumab (Actemra or RoActemra)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 82 sitesin 3 countries
Study dates: Nov 2010to Jun 2012
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to < 12.5mg/week are allowed if there is documented intolerance
Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening

Who cannot join

Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
Wheelchair bound or bedridden.
Disease modifying antirheumatic drugs (DMARDs) other than MTX.
Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
Treatment with other biologics within 4-24 weeks (depending on the biologic)
History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection

Show all 10Show fewer

Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.

Trial locations and contacts

82 sites in 3 countries.

Country

City, postcode or hospital

82 sites in 3 countries

United States74 sites

120
Amarillo, Texas
135
Austin, Texas
176
Aventura, Florida
136
Beckley, West Virginia
109
Belmont, North Carolina
174
Brooklyn, New York
133
Cedar Rapids, Iowa
170
Charlotte, North Carolina
139
Chesapeake, Virginia
150
Cincinnati, Ohio
167
Clarksburg, West Virginia
108
Columbus, Ohio
127
Covina, California
128
Dallas, Texas
100
Dayton, Ohio
186
Daytona Beach, Florida
151
DeBary, Florida
165
Duncansville, Pennsylvania
171
Freehold, New Jersey
130
Gainesville, Georgia
141
Hamden, Connecticut
103
Hot Springs, Arkansas
126
Houston, Texas
132
Houston, Texas
138
Houston, Texas
181
Houston, Texas
116
Idaho Falls, Idaho
125
Jonesboro, Arkansas
114
Jupiter, Florida
172
Kansas City, Kansas
148
La Jolla, California
111
Lewes, Delaware
102
Lincoln, Nebraska
184
Long Beach, California
177
Los Angeles, California
166
Mesa, Arizona
145
Mesquite, Texas
160
Moline, Illinois
105
Nashville, Tennessee
106
Nashville, Tennessee
143
Nassau Bay, Texas
163
New Brunswick, New Jersey
162
Newnan, Georgia
137
Norwalk, Connecticut
110
Oklahoma City, Oklahoma
104
Palo Alto, California
154
Paradise Valley, Arizona
183
Pinellas Park, Florida
115
Rochester, New York
156
Rock Island, Illinois
149
Sacramento, California
185
Saint Clair Shores, Michigan
121
Salt Lake City, Utah
122
San Antonio, Texas
158
San Diego, California
129
Santa Maria, California
178
Sarasota, Florida
153
Savannah, Georgia
118
Scottsdale, Arizona
119
Seattle, Washington
140
South Miami, Florida
168
Springfield, Illinois
112
St Louis, Missouri
134
St Louis, Missouri
113
Stockbridge, Georgia
175
Tacoma, Washington
157
Tampa, Florida
144
Tomball, Texas
152
Toms River, New Jersey
101
Trumbull, Connecticut
164
Upland, California
142
Victoria, Texas
117
Wexford, Pennsylvania
107
Wildomar, California

Other trials in United States

United Kingdom6 sites

206
Essex
205
London
204
Newcastle upon Tyne
208
Southampton
209
Torquay, Devon
201
Wigan, Lancashire

Other trials in United Kingdom

Belgium2 sites

401
Brussels
400
Liège

Other trials in Belgium

About this study

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

Read the detailed description

CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week, randomized, double-blind, placebo- and active- controlled study comparing several doses and dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in patients with active rheumatoid arthritis who have had an unsuccessful response to methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12 weeks while maintaining an adequate safety profile. In order to maintain the study blinding all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on stable weekly doses of methotrexate. Assessments during the study include evaluations of joint pain and swelling, laboratory blood and urine tests, physical examinations, vital signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will be eligible to enroll in a long-term extension study receiving CDP6038.

Conditions: Rheumatoid Arthritis
Being tested: CDP6038, Tocilizumab (Actemra or RoActemra), Placebo sc, Placebo iv
Keywords: Rheumatoid Arthritis, CDP6038, Interleukin-6, Tocilizumab
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

CDP6038Biological
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
CDP6038Biological
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
CDP6038Biological
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Tocilizumab (Actemra or RoActemra)Biological
8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
CDP6038Biological
60 mg sc at Weeks 0, 4 and 8
CDP6038Biological
240 mg sc at Weeks 0, 4 and 8
CDP6038Biological
120 mg sc at Weeks 0, 4 and 8
Placebo scOther
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Placebo scOther
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Placebo ivOther
0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Study groups in NCT01242488
Study group	Role	What they receive
CDP6038 60 mg sc every 2 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo iv
CDP6038 60 mg sc every 4 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo sc; Other: Placebo iv
CDP6038 120 mg sc every 2 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo iv
CDP6038 120 mg sc every 4 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo sc; Other: Placebo iv
CDP6038 240 mg sc every 2 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo iv
CDP6038 240 mg sc every 4 weeks plus methotrexate	Experimental	Not described Receives: Biological: CDP6038; Other: Placebo sc; Other: Placebo iv
Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate	Active comparator	Not described Receives: Biological: Tocilizumab (Actemra or RoActemra); Other: Placebo sc
Placebo sc every 2 weeks plus methotrexate	Placebo comparator	Not described Receives: Other: Placebo sc; Other: Placebo iv
Placebo sc every 4 weeks plus methotrexate	Placebo comparator	Not described Receives: Other: Placebo sc; Other: Placebo iv

What is being measured

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

Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Measured: Baseline, Week 12

Secondary outcomes (3)

American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms.
Measured: From Baseline to Week 12
American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms.
Measured: From Baseline to Week 12
American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms.
Measured: From 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.

Nov 2010Jun 2012

First posted17 Nov 2010 (estimated)
Study startNov 2010
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01242488
Sponsor's protocol ID: RA0056
Other IDs: 2010-020839-39
Status last verified: Jul 2024
First submitted: 15 Nov 2010
Last updated: 17 Jul 2024
Results posted: No
Data monitoring committee: Yes

Publications

Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18.
PubMed 24641941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
ClinicalTrials.gov ID: NCT01242488
Acronym / sponsor ID: RA0056
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, CDP6038, Interleukin-6, Tocilizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Nov 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
CDP6038 60 mg sc every 2 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo iv
CDP6038 60 mg sc every 4 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo sc, Other: Placebo iv
CDP6038 120 mg sc every 2 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo iv
CDP6038 120 mg sc every 4 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo sc, Other: Placebo iv
CDP6038 240 mg sc every 2 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo iv
CDP6038 240 mg sc every 4 weeks plus methotrexate	Experimental	Biological: CDP6038, Other: Placebo sc, Other: Placebo iv
Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate	Active comparator	Biological: Tocilizumab (Actemra or RoActemra), Other: Placebo sc
Placebo sc every 2 weeks plus methotrexate	Placebo comparator	Other: Placebo sc, Other: Placebo iv
Placebo sc every 4 weeks plus methotrexate	Placebo comparator	Other: Placebo sc, Other: Placebo iv

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to < 12.5mg/week are allowed if there is documented intolerance
Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening

Key exclusion criteria (10 listed)

Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
Wheelchair bound or bedridden.
Disease modifying antirheumatic drugs (DMARDs) other than MTX.
Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
Treatment with other biologics within 4-24 weeks (depending on the biologic)

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
CDP603860 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10	Biological	CDP6038 60 mg sc every 2 weeks plus methotrexate
CDP6038120 mg sc at Weeks 0, 2, 4 6, 8, and 10	Biological	CDP6038 120 mg sc every 2 weeks plus methotrexate
CDP6038240 mg sc at Weeks 0, 2, 4 6, 8, and 10	Biological	CDP6038 240 mg sc every 2 weeks plus methotrexate
Tocilizumab (Actemra or RoActemra)8 mg/kg intravenously (iv) at Weeks 0, 4 and 8	Biological	Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
CDP603860 mg sc at Weeks 0, 4 and 8	Biological	CDP6038 60 mg sc every 4 weeks plus methotrexate
CDP6038240 mg sc at Weeks 0, 4 and 8	Biological	CDP6038 240 mg sc every 4 weeks plus methotrexate
CDP6038120 mg sc at Weeks 0, 4 and 8	Biological	CDP6038 120 mg sc every 4 weeks plus methotrexate
Placebo sc0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10	Other	Placebo sc every 2 weeks plus methotrexate, Placebo sc every 4 weeks plus methotrexate, Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
Placebo sc0.9% Sodium chloride for injection at Weeks 2, 6 and 10	Other	CDP6038 120 mg sc every 4 weeks plus methotrexate, CDP6038 240 mg sc every 4 weeks plus methotrexate, CDP6038 60 mg sc every 4 weeks plus methotrexate
Placebo iv0.9% Sodium chloride for injection at Weeks 0, 4 and 8	Other	CDP6038 120 mg sc every 2 weeks plus methotrexate, CDP6038 120 mg sc every 4 weeks plus methotrexate, CDP6038 240 mg sc every 2 weeks plus methotrexate, CDP6038 240 mg sc every 4 weeks plus methotrexate, CDP6038 60 mg sc every 2 weeks plus methotrexate, CDP6038 60 mg sc every 4 weeks plus methotrexate, Placebo sc every 2 weeks plus methotrexate, Placebo sc every 4 weeks plus methotrexate

Primary outcome

Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Time frame: Baseline, Week 12

3 secondary outcomes

American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms.
Time frame: From Baseline to Week 12
American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms.
Time frame: From Baseline to Week 12
American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms.
Time frame: From Baseline to Week 12

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Derived from this study: PubMed 24641941Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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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.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

82 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 and Tocilizumab (Actemra or RoActemra) in people with Rheumatoid Arthritis, run by UCB Pharma at 82 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, United Kingdom, Belgium. 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 (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (time frame: Baseline, 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 NCT01242488, 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 17 Jul 2024.