Rheumatoid ArthritisPhase 2NCT02287922
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
A Phase 2 study testing ALX-0061 and Tocilizumab in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 83 sites in 14 countries.
Trial summary
The primary objective of this study is: To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ALX-0061 and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 83 sitesin 14 countries
- Study dates
- Mar 2015to Jul 2016
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
- Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
- Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
- Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
- Others as defined in the protocol
Who cannot join
- Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.
- Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
- Others as defined in the protocol.
Trial locations and contacts
83 sites in 14 countries.
83 sites in 14 countries
United States17 sites
Investigator Site
Albuquerque, New Mexico, 87102
Investigator Site
Birmingham, Alabama, 35216
Investigator Site
Charleston, South Carolina, 29406
Investigator Site
Hemet, California, 92543
Investigator site
Hialeah, Florida, 33016
Investigator Site
Homestead, Florida, 33030
Investigator Site
La Palma, California, 90712
Investigator site
Los Angeles, California, 90017
Investigator Site
Los Angeles, California, 90036
Investigator Site
Memphis, Tennessee, 38119
Investigator Site
Mesquite, Texas, 75150
Investigator Site
New York, New York, 10018
Investigator Site
Orlando, Florida, 32804
Investigator site
Overland Park, Kansas, 66209
Investigator Site
Stockbridge, Georgia, 30281
Investigator site
Ventura, California, 93003
Investigator Site
Worcester, Massachusetts, 01605
Poland10 sites
Investigator Site
Bydgoszcz
Investigator Site 2
Elblag, 82300
Investigator Site
Elblag
Investigator Site
Gdynia
Investigator Site
Grodzisk Mazowiecki, 05825
Investigator Site
Lublin, 20582
Investigator SIte
Poznan, 60773
Investigator Site
Sochaczew, 96500
Investigator Site
Torun, 87100
Investigator Site
Warsaw, 02653
Hungary8 sites
Investigator Site
Baja, 6500
Investigator Site
Budapest
Investigator Site
Esztergom
Investigator site
Gyula, 5700
Investigator Site
Székesfehérvar, 8000
Investigator Site
Szikszó, 3800
Investigator Site
Szombathely, 9700
Investigator Site
Veszprém, 8200
Bulgaria7 sites
Investigator Site
Burgas
Investigator Site
Pleven
Investigator Site 1
Plovdiv
Investigator Site 2
Plovdiv
Investigator Site 1
Rousse
Investigator Site 2
Rousse
Investigator Site
Sofia
Mexico7 sites
Investigator Site
Culiacán
Investigator Site
León
Investigator Site 1
Mexico City
Investigator Site 2
Mexico City
Investigator Site
Mexico City
Investigator Site 1
Monterrey
Investigator Site 2
Monterrey
Czechia6 sites
Investigator Site
Brno, 602000
Investigator Site
Olomouc
Investigator Site
Ostrava, 70300
Investigator Site 1
Prague
Investigator Site 2
Prague
Investigator Site
Zlín
Spain6 sites
Investigator Site
Córdoba
Investigator Site
Madrid, 28007
Investigator Site
Santander, 39300
Investigator Site 2
Santander
Investigator Site 1
Santiago de Compostela
Investigator Site 2
Santiago de Compostela
Georgia5 sites
Investigator Site
Tbilisi, 0102
Investigator Site 1
Tbilisi, 0159
Investigator Site 2
Tbilisi, 0159
Investigator Site
Tbilisi, 0160
Investigator Site
Tbilisi, 0179
Serbia4 sites
Investigator Site 1
Belgrade
Investigator Site 2
Belgrade
Investigator Site 3
Belgrade
Investigator Site
Niška Banja
Belgium3 sites
Investigator Site
Brussels, 1200
Investigator Site
Ghent, 9000
Investigator Site
Liège, 4000
Germany3 sites
Investigator Site
Berlin
Investigator Site
Frankfurt
Investigator Site
Hamburg
Romania3 sites
Investigator Site
Bucharest
Investigator Site
Oradea
Investigator Site
Timișoara
North Macedonia2 sites
Investigator Site 1
Skopje, 1000
Investigator Site 2
Skopje, 1000
About this study
Official title: A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
The primary objective of this study is:
- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
The secondary objectives of this study are:
- To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development.
- To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ALX-0061, Placebo, 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.
ALX-0061Biological
PlaceboBiological
TocilizumabBiological
| Study group | Role | What they receive |
|---|---|---|
| ALX-0061 150 mg q4w | Experimental | ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. Receives: Biological: ALX-0061; Biological: Placebo |
| ALX-0061 150 mg q2w | Experimental | ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. Receives: Biological: ALX-0061; Biological: Placebo |
| ALX-0061 225 mg q2w | Experimental | ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. Receives: Biological: ALX-0061 |
| TCZ 162 mg q1w or q2w | Active comparator | Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Receives: Biological: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
ACR 20 response is defined as:
- 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
- 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND
- 20% improvement in 3 of the following 5 areas relative to Week 0:
- Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])
- Subject's Global Assessment of Disease Activity (VASPA)
- Physician's Global Assessment of Disease Activity (VASPHA)
- Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
- C-reactive protein (CRP) level
The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.
Measured: Week 12
Secondary outcomes (20)
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12
ACR50/70 response is defined as:
- 50/70% improvement in TJC (68 joints) relative to Week 0 AND
- 50/70% improvement in SJC (66 joints) relative to Week 0 AND
- 50/70% improvement in 3 of the following 5 areas relative to Week 0:
- Subject's Assessment of Pain (100 mm - VAS)
- Subject's Global Assessment of Disease Activity (VASPA)
- Physician's Global Assessment of Disease Activity (VASPHA)
- Subject's assessment of physical function as measured by HAQ-DI
- CRP level
This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 12 were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12
DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96
Low disease activity = 2.6 ≤ DAS28 ≤ 3.2
Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)
Low disease activity = 2.6 ≤ DAS28 ≤ 3.2
Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)
Low disease activity: 3.3 < SDAI ≤ 11.0
Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12
CDAI = TJC28 + SJC28 + VASPA + VASPHA
Low disease activity: 2.8 < CDAI ≤ 10
Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12
EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline.
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)
Remission = DAS28(ESR) < 2.6
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects in Remission Using SDAI at Week 12
SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)
Remission: SDAI ≤ 3.3
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects in Remission Using CDAI at Week 12
CDAI = TJC28 + SJC28 + VASPA + VASPHA
Remission: CDAI ≤ 2.8
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12
Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.
Measured: Week 12
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome).
Missing values were imputed with the last non-missing observation.
Measured: From baseline until Week 12
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12
The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Low score indicates greater disability.
Measured: From baseline until week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12
The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Measured: From baseline until Week 12
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)
Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).
Measured: From baseline until Week 12
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12
Measured: From baseline until Week 12
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Measured: From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
Measured: From baseline until Week 12
Number of Treatment-emergent Adverse Event by Severity
Measured: From baseline until Week 12
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event
treatment related = considered at least possibly related to study drug by the Investigator
Measured: From baseline until Week 12
Number of Treatment-related Treatment-emergent Adverse Event
treatment related = considered at least possibly related to study drug by the Investigator
Measured: From baseline until Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287922
- Sponsor's protocol ID
- ALX0061-C202
- Other IDs
- 2014-003012-36, 2014
- Status last verified
- Aug 2019
- First submitted
- 5 Nov 2014
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
- ClinicalTrials.gov ID
- NCT02287922
- Acronym / sponsor ID
- ALX0061-C202
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is:
- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
The secondary objectives of this study are:
- To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development.
- To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALX-0061 150 mg q4w | Experimental | Biological: ALX-0061, Biological: PlaceboALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. |
| ALX-0061 150 mg q2w | Experimental | Biological: ALX-0061, Biological: PlaceboALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. |
| ALX-0061 225 mg q2w | Experimental | Biological: ALX-0061ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. |
| TCZ 162 mg q1w or q2w | Active comparator | Biological: TocilizumabOpen-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
- Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
- Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
- Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
- Others as defined in the protocol
Key exclusion criteria (5 listed)
- Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.
- Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for RA.
- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
- Others as defined in the protocol.
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 |
|---|---|---|
| ALX-0061 | Biological | ALX-0061 150 mg q2w, ALX-0061 150 mg q4w, ALX-0061 225 mg q2w |
| Placebo | Biological | ALX-0061 150 mg q2w, ALX-0061 150 mg q4w |
| Tocilizumab | Biological | TCZ 162 mg q1w or q2w |
Primary outcome
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
Time frame: Week 12
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale [VAS]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.
20 secondary outcomes
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12
Time frame: Week 12
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12
Time frame: Week 12
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12
Time frame: Week 12
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12
Time frame: Week 12
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12
Time frame: Week 12
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12
Time frame: Week 12
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12
Time frame: Week 12
Number and Percentage of Subjects in Remission Using SDAI at Week 12
Time frame: Week 12
Number and Percentage of Subjects in Remission Using CDAI at Week 12
Time frame: Week 12
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12
Time frame: Week 12
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Time frame: From baseline until Week 12
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12
Time frame: From baseline until week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12
Time frame: From baseline until Week 12
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)
Time frame: From baseline until Week 12
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12
Time frame: From baseline until Week 12
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Time frame: From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity
Time frame: From baseline until Week 12
Number of Treatment-emergent Adverse Event by Severity
Time frame: From baseline until Week 12
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event
Time frame: From baseline until Week 12
Number of Treatment-related Treatment-emergent Adverse Event
Time frame: From baseline until Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- 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.
Medical Monitor, MD study director
Ablynx, a Sanofi company
83 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX-0061 and Tocilizumab in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 83 sites in 14 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 5 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Poland, Hungary, Bulgaria, Mexico and 9 more countries. 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 21 Aug 2019). 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?
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 (time frame: Week 12). 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 21 Aug 2019.